Medical policy and regulation
Medical policy and regulation in healthcare ensure the safety, efficacy and quality of medical treatments and services by setting standards and guidelines for medical practices, drug development and healthcare delivery. Continuous updates and oversight in medical policy and regulation help guide clinical innovation and refine current approaches to healthcare.
Top Stories
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News
25 Oct 2024
TreeHouse Foods expands recall of waffles, pancakes
TreeHouse Foods expands its recall of waffles and pancakes from major retailers, like Walmart, Target, Aldi, Dollar General, Kroger, Publix, Whole Foods, Trader Joe's and more. Continue Reading
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17 Oct 2024
Medicare drug price negotiations impact non-chain pharmacies
Although Medicare drug price negotiations intend to expand medication access, independent pharmacies are facing challenges associated with reimbursement and PBM strategies. Continue Reading
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08 Jul 2022
FDA Expands EUA to Allow Pharmacists to Prescribe Paxlovid
On July 6, 2022, the FDA updated their emergency use authorization (EUA) for Paxlovid, now allowing pharmacists to prescribe Paxlovid. Continue Reading
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07 Jul 2022
FDA Releases Drug Safety Communication regarding Cancer Drug, Copiktra
The FDA recently released a warning, via drug safety communication, on the potential risks associated with the cancer drug Copiktra. Continue Reading
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30 Jun 2022
Antitrust Lawsuit against Generic Pharmaceutical Companies Is Amended
An antitrust lawsuit brought by 51 plaintiffs against a group of pharmaceutical companies was constrained by a federal judge, limiting the allowed financial penalty. Continue Reading
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28 Jun 2022
USPTF Updates Recommendations on Supplements to Prevent Cancer
The United States Preventative Task Force (USPTF) updates the recommendations on using supplements to prevent cardiovascular disease and cancer. Continue Reading
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24 Jun 2022
FDA Expanded Approval of Skyrizi for Treatment of Crohn’s Disease
On June 17, the FDA expanded the approval of Skyrizi for the treatment of Crohn’s disease. Continue Reading
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20 Jun 2022
Could the Approval of Albrioza by Health Canada for ALS Impact the FDA Ruling?
The approval of Albrioza, a drug developed by Amylyx Pharmaceuticals, by Health Canada for the treatment of ALS may have implications for future FDA approval. Continue Reading
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17 Jun 2022
FDA Advisory Board Unanimously Votes to Approve Pfizer COVID Vaccine for Kids under 5
At their committee meeting, the Vaccines and Related Biological Products FDA advisory board voted to approve the Pfizer COVID vaccine for children under 5. Continue Reading
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16 Jun 2022
FDA Accepts Biologic Application for Keytruda Treatment of Lung Cancer
The FDA will review Merck’s immunotherapy after a clinical trial demonstrated its efficacy in treating non-small cell lung cancer. Continue Reading
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15 Jun 2022
Olumiant Becomes the First FDA-Approved Systemic Treatment for Alopecia Areata
On Monday, June 13, the FDA approved Olumiant, generically known as baricitinib, as the first systemic therapy for Alopecia Areata. Continue Reading
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14 Jun 2022
Bluebird Bio’s Rare Disease Gene Therapies Recommended for FDA Approval
Bluebird bio received good news last week after an FDA panel recommended two of their gene therapies for approval. Continue Reading
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13 Jun 2022
US FDA Approves GSK’s Priorix Measles, Mumps, and Rubella Vaccine
The US FDA has approved GSK’s Priorix measles, mumps, and rubella (MMR) vaccine for individuals 12 months and older. Continue Reading
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07 Jun 2022
FDA Refuses to File Aeglea Biologics License Application
The Biotech Firm Aeglea received a refusal to file from the FDA for its biologic pegzilarginase used to treat rare diseases. Continue Reading
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24 May 2022
FDA Issues Guidance for Dietary Supplement Marketplace
Draft guidance published on Thursday will increase the necessary safety information made available by dietary supplement manufacturers. Continue Reading
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28 Apr 2022
FDA Proposes Ban on All Flavored Cigarettes, Cigars
The FDA ban would make illegal all cigarette and cigar flavorings. Continue Reading
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15 Feb 2022
FDA Issues Draft Guidance for Development of Non-Opioid Analgesics
The guidance provides recommendations to companies developing non-opioids analgesics for acute pain lasting up to 30 days, typically in response to some form of trauma or surgery. Continue Reading
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15 Feb 2022
Gilead, ViiV Healthcare Enter $1.25B Settlement Over HIV Drug
In 2018, Viiv Healthcare, GSK, and Shionogi alleged that Gilead’s HIV drug, Biktarvy, containing three HIV integrase inhibitors, infringed their patents relating to dolutegravir. Continue Reading
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08 Feb 2022
FDA Proposes Rule to Strengthen Pharmaceutical Supply Chain
FDA’s proposed rule will clarify and provide consistency for wholesale distributors and third-party logistics providers seeking licensure to boost the pharmaceutical supply chain. Continue Reading
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22 Sep 2021
FDA Approves First Biosimilar to Treat Macular Degeneration
FDA has approved a biosimilar to treat neovascular age-related macular degeneration, macular edema following retinal vein occlusion, and myopic choroidal neovascularization. Continue Reading
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16 Sep 2021
Pharma Companies Challenge Federal Plans to Lower Drug Pricing
In a letter to Congress, pharmaceutical companies challenge government price “negotiation” and suggest bipartisan solutions to lower drug pricing and patients out of pocket costs. Continue Reading
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10 Sep 2021
Biden Administration Unveils Plan to Lower Prescription Drug Prices
The plan, guided by HHS principles to lower prescription drug prices through competition, innovation, and transparency, will boost patient access and adherence to treatments. Continue Reading
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04 Aug 2021
Roche Gets FDA Priority Review for Non-Small Cell Lung Cancer Drug
FDA expects to make its decision on approval of Roche’s non-small cell lung cancer drug Tecentriq by December 2021. Continue Reading
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30 Jul 2021
FDA Approves Mylan’s Interchangeable Biosimilar Insulin Product
Mylan’s Semglee is the first interchangeable biosimilar product FDA approved in the US for diabetes treatment. Continue Reading
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26 Jul 2021
FDA Grants Breakthrough Therapy for Roche’s MDS Treatment
Roche’s combination MDS treatment is intended for adult patients with previously untreated, high-and very high-risk MDS. Continue Reading
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23 Jun 2021
Orphazyme Receives FDA Complete Response Letter for Rare Disease
FDA is seeking additional qualitative and quantitative evidence to further confirm the validity of the most relevant clinical domains of the rare disease. Continue Reading
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17 Jun 2021
Congress Reintroduces PASTEUR Act to Combat Antimicrobial Resistance
The PASTEUR Act, first introduced in September 2020, will help to improve antimicrobial resistance and ensure domestic availability of medications when needed. Continue Reading
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14 Jun 2021
FDA Boosts Johnson & Johnson’s COVID-19 Vaccine for Export
FDA authorized for use two batches of Johnson & Johnson’s COVID-19 vaccine manufactured at the Emergent BioSolutions facility in Baltimore, but also told the company to discard 60 million doses. Continue Reading
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14 Jun 2021
US Acquires 1.7B Courses of Merck’s COVID-19 Treatment
The government will procure courses of Merck’s COVID-19 treatment, MK-4482, pending emergency use authorization or approval from FDA. Continue Reading
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07 Jun 2021
Prescription Drug Spending Expected to Reach $400B in 2025
An IQVIA analysis found that new brand launches will contribute to $133B in prescription drug spending growth through 2025, which is higher than previous years. Continue Reading
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03 Jun 2021
Moderna, UNICEF to Supply COVID-19 Vaccine on Behalf of COVAX
The companies will supply 34 million doses of Moderna’s COVID-19 vaccine in the fourth quarter of 2021 and 466 million doses in 2022. Continue Reading
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03 Jun 2021
FDA Approves First Targeted Non-Small Cell Lung Cancer Therapy
In a study of 124 patients with metastatic KRAS G12C-mutated non-small cell lung cancer, overall response rate was 36%. 58% of those patients had a duration of response of 6 months or longer. Continue Reading
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02 Jun 2021
Janssen’s Teclistamab Gets FDA Breakthrough Therapy Designation
The FDA breakthrough therapy designation follows the European Medicines Agency’s PRIME designation for Janssen’s therapy intended for the treatment of relapsed or refractory multiple myeloma. Continue Reading
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01 Jun 2021
CMS Proposes Delay of Medicaid Value-Based Payment Requirements
Delaying the Medicaid value-based drug payment requirements would allow stakeholders to implement the pricing policy in a way that assures patient access is protected, CMS stated. Continue Reading
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28 May 2021
8 Companies Claim CVS Health Overcharged for Prescription Drugs
8 companies are filing a lawsuit claiming that CVS offered hundreds of prescription drugs at low discounted prices through its cash discount programs. Continue Reading
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27 May 2021
Emergency Use Authorization Granted for GSK-Vir COVID-19 Antibody
A Phase 1/2/3 clinical trial showed that the monoclonal COVID-19 antibody therapy was 85% effective in reducing hospitalization or death in infected patients. Continue Reading
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19 May 2021
FDA Guidance Addresses Master Protocols for COVID-19 Drugs
New FDA guidance touches on master protocol and stand-alone trials for COVID-19 drugs, as well as FDA’s administrative and procedural recommendations. Continue Reading
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18 May 2021
Abbott’s Navitor for Severe Aortic Stenosis Receives CE Mark
Abbott’s TAVI system, Navitor, is a minimally invasive device that is available to individuals with severe aortic stenosis who are at high or extreme surgical risk. Continue Reading
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12 May 2021
EMA Assesses Blood Clots, Other Side Effects of COVID-19 Vaccines
Among the agency’s recommendations are a change to product information for the Pfizer-BioNTech COVID-19 vaccine, as well as assessment of COVID-19 Vaccine AstraZeneca for GBS. Continue Reading
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10 May 2021
Out-of-Pocket Costs for Brand-Name Medications Increased 15%
A JAMA study found that for 53.7% of patients who paid drug deductibles or coinsurance between 2015 and 2017, median out-of-pocket costs increased by 15% for brand-name medications. Continue Reading
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06 May 2021
Biden Administration Backs Waiver of COVID-19 Intellectual Property
In efforts to speed up the global distribution of COVID-19 vaccines, the Biden administration has announced its support for waiving COVID-19 vaccine intellectual property. Continue Reading
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26 Apr 2021
FDA, CDC Lift Pause of Johnson & Johnson’s COVID-19 Vaccine
The agencies determined that the known and potential benefits of the COVID-19 vaccine outweigh its known and potential risks in individuals 18 years of age or older. Continue Reading
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12 Apr 2021
Gilead’s Trodelvy Gets FDA Nod for Breast Cancer Treatment
FDA based its approval of Gilead’s triple-negative breast cancer drug Todelvy on a Phase 3 study, which found that it reduced risk of disease worsening or death by 57%. Continue Reading
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08 Apr 2021
FTC Challenges $7.1B Illumina-Grail Pharma Acquisition Deal
FTC alleges that the proposed pharma acquisition deal will diminish innovation in the US market for multi-cancer detection tests. Continue Reading
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07 Apr 2021
Biden Focuses on Opioids in Prescription Drug Policy Priorities
The prescription drug policy priorities include expanding access to evidence-based treatment, addressing racial equity issues, and reducing the supply of illicit substances. Continue Reading
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06 Apr 2021
J&J Takes Over Vaccine Production at Plant That Spoiled 15M Doses
The US tapped Johnson & Johnson to run COVID-19 vaccine production at Emergent Biosolutions’ Baltimore plant after 15M doses of the vaccine were contaminated last month. Continue Reading
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06 Apr 2021
FDA Makes Revisions to Moderna’s COVID-19 Vaccine Authorization
FDA clarifies the number of COVID-19 vaccine doses per vial and authorizes the availability of an additional multi-dose vial to help bolster vaccination efforts. Continue Reading
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01 Apr 2021
FDA Approves First Cell-Based Gene Therapy for Multiple Myeloma
Bristol Myers Squibb and bluebird bio’s Abecma is the first cell-based gene therapy approved by FDA for the treatment of adult patients with multiple myeloma. Continue Reading
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25 Mar 2021
FDA Grants First Marketing Approval for COVID-19 Diagnostic Test
BioFire Respiratory Panel 2.1 is the first COVID-19 diagnostic test granted marketing authorization using the De Novo review pathway. Continue Reading
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11 Mar 2021
FDA Authorizes First At-Home Molecular COVID-19 Diagnostic Test
FDA authorized Cue Health’s at-home, molecular COVID-19 diagnostic test for adults and children two years of age and older when swabbed by an adult. Continue Reading
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01 Mar 2021
FDA Authorizes Johnson & Johnson’s Single-Dose COVID-19 Vaccine
The emergency use authorization is based on Phase 3 data, which showed that the COVID-19 vaccine was 67% effective in preventing moderate-to-severe coronavirus 14 days after vaccination. Continue Reading
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26 Feb 2021
Flu Vaccine Patterns Hint To Effective COVID-19 Vaccination Efforts
Flu vaccine strategies give a glimpse into the challenges of COVID-19 vaccination efforts. Effective COVID-19 vaccine rollout can take several pointers from the flu’s failings and successes. Continue Reading
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23 Feb 2021
FDA Approves G1’s Cosela to Prevent Damage from Chemotherapy
FDA authorized the drug to be administered intravenously as a 30-minute infusion within four hours prior to the start of chemotherapy in lung cancer patients. Continue Reading
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19 Feb 2021
HHS Releases New Actions to Expand COVID-19 Testing Across the US
The proposed actions will boost the availability of COVID-19 testing, increase domestic manufacturing of tests and testing supplies, and prepare the nation for the threat of variants. Continue Reading
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18 Feb 2021
WHO Grants Emergency Use to AstraZeneca’s COVID-19 Vaccine
AstraZeneca’s COVID-19 vaccine can be administered at a four to 12-week interval to individuals 18 years of age and older, including those over 65. Continue Reading
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10 Feb 2021
FDA Approves Eli Lilly’s Combination COVID-19 Antibody Treatment
The combination COVID-19 antibody treatment can now be administered to adult and pediatric patients and to those who are at high risk for progressing to severe disease. Continue Reading
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08 Feb 2021
PhRMA Challenges 340B Drug Pricing Program ADR Rule
PhRMA asserted that the new 340B Drug Pricing Program administrative dispute resolution rule is not the product of reasoned decision-making and is unlawful. Continue Reading
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08 Feb 2021
HHS Expands Workforce Authorized to Administer COVID-19 Vaccines
The HHS guideline states that any physician, registered nurse, or practical nurse whose license expired within the past five years can administer COVID-19 vaccines. Continue Reading
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28 Jan 2021
Biden’s Executive Order on Expanding Access to COVID-19 Therapies
An executive order signed by President Joe Biden looks to expand access to COVID-19 therapies for all Americans by supporting drug research, healthcare workers, and patients. Continue Reading
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25 Jan 2021
US to Remain WHO Member, Join Global COVID-19 Vaccine Program
Remaining a WHO member will allow the US to join COVAX, a global COVID-19 vaccine program, according to NIAID Director Anthony Fauci, MD. Continue Reading
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21 Jan 2021
Biden Executive Order Details New COVID-19 Response Plan
An executive order signed by President Biden on his first day looks to boost COVID-19 supply, including vaccines and tests, as well as monitor biological and pandemic threats. Continue Reading
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21 Jan 2021
Janet Woodcock Acting FDA Commissioner After Hanh’s Departure
Janet Woodcock, who has been at FDA for 34 years, will serve as Acting FDA Commissioner after Hanh’s resignation on Wednesday. Continue Reading
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20 Jan 2021
HHS Expands Access to Buprenorphine for Opioid Use Disorder
Under HHS’s guidelines, which will soon be published, physicians will be exempt from certain certification requirements needed to prescribe buprenorphine for opioid use disorder. Continue Reading
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13 Jan 2021
HHS Distributes $22B to States for COVID-19 Testing, Vaccinations
Over $19 billion of the funding will support COVID-19 testing, contact tracing, containment, and mitigation, while $3 billion will support various coronavirus vaccination activities. Continue Reading
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11 Jan 2021
EU Grants Emergency Use for Moderna’s mRNA COVID-19 Vaccine
The conditional marketing authorization for the mRNA COVID-19 vaccine paves the way for active immunization of individuals in member countries. Continue Reading
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07 Jan 2021
AstraZeneca’s COVID-19 Vaccine Gains Emergency Use in 6 Countries
The authorization of AstraZeneca’s COVID-19 vaccine in six countries is based on clinical trial results which showed that the vaccine was safe and effective at preventing the coronavirus. Continue Reading
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06 Jan 2021
FDA Warns Against Half-Dosing Pfizer, Moderna COVID-19 Vaccines
The agency said any changes to the COVID-19 vaccine dosing schedule is premature and not rooted in available evidence. Continue Reading
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05 Jan 2021
UK Authorizes Emergency Use of AstraZeneca’s COVID-19 Vaccine
This is the first emergency authorization for COVID-19 Vaccine AstraZeneca, formerly known as AZD1222. Continue Reading
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04 Jan 2021
HHS Unveils 3-Part Plan for Supporting COVID-19 Testing Efforts
The plan includes weekly shipments of COVID-19 testing supplies to states and allocating an extra 30Mof Abbott’s COVID-19 tests to support testing among high-risk populations. Continue Reading
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30 Dec 2020
GSK Receives FDA Approval for Chronic Disease Treatment
FDA extended its 2019 approval of GSK’s chronic disease treatment, both intravenous and subcutaneous formulations, to include lupus nephritis and lupus erythematosus. Continue Reading
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28 Dec 2020
CA Launches Campaign for Safe, Fair COVID-19 Vaccine Distribution
The campaign, “Vaccinate All 58,” will allow for COVID-19 vaccines to be administered in phases by prioritizing groups according to risk and level of exposure. Continue Reading
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23 Dec 2020
HHS Doles Out Additional $227M for COVID-19 Vaccine Preparedness
After awarding $200 million for COVID-19 vaccine preparedness back in September, the agency will double the funding to prepare, track, and test in all 50 states and US territories. Continue Reading
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22 Dec 2020
Supreme Court Allows States to Regulate Pharmacy Benefit Managers
The decision ruled in favor of patient and independent pharmacy groups that looked to stop pharmacy benefit managers from keeping reimbursement rates low for generic drugs. Continue Reading
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22 Dec 2020
CMS Rule Allows Payers to Negotiate Prescription Drug Pricing
A final rule from CMS will enable payers, including Medicaid, to negotiate prescription drug pricing based on patient outcomes. Continue Reading
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21 Dec 2020
FDA Issues EUA for Abbott’s At-Home COVID-19 Antigen Test
EUA temporarily approved the use of the at-home COVID-19 antigen test for adults and certain children to boost access to testing options. Continue Reading
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18 Dec 2020
FDA Authorizes First At-Home, OTC COVID-19 Diagnostic Test
FDA approved emergency use authorization for Ellume’s COVID-19 diagnostic test that can be used by patients in their home and is available over the counter. Continue Reading
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15 Dec 2020
Pharma Organizations Sue HHS Over Most Favored Nation Drug Rule
The organizations claimed that the most favored nation drug rule exceeds HHS’ statutory authority, raises constitutional questions, and fails to follow required rulemaking procedures. Continue Reading
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14 Dec 2020
FDA Issues EUA For Pfizer-BioNTech COVID-19 Vaccine
The FDA has announced the first EUA for the COVID 19 vaccine from Pfizer-BioNTech, allowing for distribution to millions across the country. Continue Reading
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11 Dec 2020
FDA Says It Will Approve EUA for Pfizer’s COVID-19 Vaccine
FDA will work towards finalization of an emergency use authorization for Pfizer-BioNTech’s COVID-19 vaccine, BNT162b2, after it was found 95% effective in a Phase 3 study. Continue Reading
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09 Dec 2020
HHS Ensures Access to COVID-19 Vaccines for Tribal Health Programs
Tribal health programs and Urban Indian Organizations now have the option to receive doses of a COVID-19 vaccine either through the Indian Health Service or their respective state, HHS stated. Continue Reading
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08 Dec 2020
FDA Authorizes First Influenza, COVID-19 Diagnostic Test
The COVID-19 diagnostic test is authorized for prescription use with the Quest Diagnostic Self-Collection Kit for COVID-19 Flu when at-home collection is approved by an individual’s healthcare provider. Continue Reading
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04 Dec 2020
Roche Receives FDA Approval for COVID-19 Antibody Test
The COVID-19 antibody test detects antibodies against the SARS-CoV-2 spike protein, which is the target of many coronavirus vaccines in development. Continue Reading
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03 Dec 2020
HHS, DoD to Increase Domestic Swab Production for COVID-19 Tests
The grant to Puritan Medical Products will increase domestic swab production of the company’s Cue Sample Swabs, which are exclusively used with Cue Health’s COVID-19 test. Continue Reading
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02 Dec 2020
UK Approves COVID-19 Vaccine from Pfizer, BioNTech
This is the first-ever emergency use authorization of a COVID-19 vaccine following a worldwide Phase 3 trial of the vaccine developed by Pfizer and BioNTech. Continue Reading
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27 Nov 2020
FDA Grants Emergency Use to Regeneron’s COVID-19 Antibody Cocktail
Providers can administer the COVID-19 antibody cocktail to infected adult and pediatric patients 12 years or older and to individuals who are at high risk of severe coronavirus. Continue Reading
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24 Nov 2020
Trump Issues New Rules to Lower Prescription Drug Pricing
Part of the Trump Administration’s efforts to lower prescription drug pricing, the rules could save seniors billions of dollars by eliminating middlemen and finalizing the Most Favored Nation Rule. Continue Reading
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19 Nov 2020
FDA Releases Guidance to Encourage Clinical Trial Diversity
The guidance to encourage clinical trial diversity includes inclusion of groups that are often overlooked in clinical trials, including women, racial minorities, children, and older adults. Continue Reading
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10 Nov 2020
FDA Authorizes Serology Test to Detect Neutralizing Antibodies
The COVID-19 serology test is the first test to specifically detect neutralizing antibodies in patient samples without the use of a live virus, FDA stated. Continue Reading
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04 Nov 2020
HHS, DoD Announce $12.7M Contract to Increase COVID-19 Testing
The federal departments will boost the production of two COVID-19 tests to 400,000 units per week by May 2021, which is 20 times the current output. Continue Reading
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03 Nov 2020
FDA Publishes List of Essential Medicines to Address COVID-19
The list of essential medications will ensure US citizens are protected against outbreaks of emerging infectious diseases, such as COVID-19, as well as chemical, biological, radiological, and nuclear threats. Continue Reading
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27 Oct 2020
HHS Guidance Further Expands Access to COVID-19 Vaccines, Tests
The guidance authorizes both qualified pharmacy technicians and state-authorized pharmacy interns to administer an FDA-approved COVID-19 vaccine to individuals aged three and older. Continue Reading
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23 Oct 2020
Purdue Pharmaceuticals Pleads Guilty in $8.3B Opioid Settlement
In the largest settlement ever reached with a pharma company, Purdue will pay $8.3 billion and will plead guilty to criminal charges in connection with its role in the US opioid crisis. Continue Reading
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22 Oct 2020
Combating Antimicrobial Resistance Through Global Market Reform
A Pioneer Institute report found that “push” and “pull” funding can reform the current market to reduce the antimicrobial resistance crisis globally. Continue Reading
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09 Oct 2020
What is Medicare Part D, What Does It Mean for Pharma?
Medicare Part D plans fill a coverage gap, giving members voluntary coverage for outpatient prescription drugs. Continue Reading
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08 Oct 2020
FDA Issues Guidance for Emergency Use of COVID-19 Vaccines
The guidance included recommendations regarding the data and information needed to support the issuance of an emergency use authorization for a COVID-19 vaccine. Continue Reading
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06 Oct 2020
Hospitals Go Back to Purchasing Remdesivir from Distributor
Federal government oversight of the allocation of Gilead’s antiviral, remdesivir, is no longer needed, according to HHS. Continue Reading
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05 Oct 2020
HHS to Share Best Practices for Point-of-Care COVID-19 Testing
With The Rockefeller Foundation, HHS is launching a pilot in select cities to identify best practices for boosting point-of-care COVID-19 testing. Continue Reading
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02 Oct 2020
CDC to Dole Out $200M for COVID-19 Vaccine Preparedness
The funding is from the CARES Act for boosting COVID-19 vaccine preparedness, including distribution and administration of effective vaccines as soon as it becomes available. Continue Reading
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29 Sep 2020
Gilead to Pay $97M to Resolve Healthcare Fraud Allegations
The healthcare fraud allegations claimed that Gilead used a foundation as a conduit to pay the copays of thousands of Medicare patients taking its pulmonary arterial hypertension drug. Continue Reading
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28 Sep 2020
FDA Finalizes Rule on Prescription Drug Importation from Canada
The final rule fulfills President Trump’s July 2020 Executive Order on drug pricing, which called for prescription drug importation from Canada in certain FDA-authorized programs. Continue Reading
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28 Sep 2020
Bristol Myers Squibb Gets FDA Priority Review for T-Cell Therapy
The FDA priority review for the T-cell therapy comes four months after the company received a Refusal to File letter regarding the Biologics License Application for the same therapy. Continue Reading
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25 Sep 2020
Exploring the Most Favored Nation Approach for Drug Pricing
President Trump’s latest favored nation executive order is an attempt to lower prescription drug costs in the US by relying on international price competition. Continue Reading