CMS Sets Date for Medicare Drug Price Negotiation Final Guidance for July
The US Centers for Medicare and Medicaid Services (CMS) will aim to release the final draft guidance on the upcoming Medicare drug pricing negotiations instantiated by the passage of the Inflation Reduction Act. The draft guidance was released last month and is currently open for comments. The agency, according to its administrator Chiquita Brooks-Lasure, has already begun talks with manufacturers.
Internal Tensions Brewing in Generics Industry Group
The Association for Accessible Medicines, a trade organization for drugmakers producing generics, is undergoing an internal riff that may jeopardize its lobbying power. This follows substantial financial losses and a series of high-profile layoffs. Group insiders lay part of the blame on the board of directors who they argue repeatedly fumbled key organizational decisions.
FDA Mulling Over Next Move Following Mifepristone Ruling
The US Food and Drug Administration’s authority to approve medications is on the line, following a Texas judge shooting down the decades-old approval of the abortion medication mifepristone. With this development, the agency is looking for ways to preserve its powers while keeping mifepristone on the market. The strategy will depend on an appeal at the Fifth Circuit tomorrow.
Drug Purchasing Group Sues Takeda Over Gout Drug Pay-For-Delay Deal
Takeda is once again in hot water over allegations it participated in a pay-for-delay deal, this time over its gout drug Colcrys. The plaintiffs, a group of drug distributors, claim that Takeda patent settlements with several generics manufacturers delayed the release of cheaper alternative, preventing price drops for the millenia-old drug.
Biotech Execs Weigh In on Mifepristone Ruling
In an amicus brief filed by a group of organizations, industry groups, and several biotech executives, writers argue that last week’s ruling overturning the US Food and Drug Administration’s (FDA’s) approval of mifepristone, a key component of the abortion pill, will “upend” the agency’s approval process for new drugs. This change, the authors warn, would harm patients and cut back research investments into drug development, as any drug may be pulled from market based on a judge’s whims.
Real-World Data Study Shows Biosimilar Rituximab for Rheumatoid Arthritis Safe and Effective
A new real-world data (RWD) study published in Rheumatology International found that patients with rheumatoid arthritis who switched from Roche’s biosimilar rituximab to Rixathon’s version of the biosimilar did not suffer any deterioration. Patients who had not taken any version of rituximab also saw similar benefits.
Pharma and FDA Wary of Dueling Texas and Washington Abortion Pill Rulings
Last week’s ruling in a US federal court that struck down the decades-old approval of mifepristone, a key drug in the abortion pill, has the US Food and Drug Administration (FDA) and the entire pharma industry on edge. The ruling, according to some legal experts, would undermine the agency’s ability to independently approve drugs based on scientific evidence. Another ruling last Friday ordered the FDA to continue providing the drug to 17 states.
US HHS Secretary Becerra Warns Texas Abortion Pill Ruling Could Imperil Entire FDA Approval Process
Following a ruling invalidating the approval of mifepristone, a key component of the abortion pill, US Health and Human Services Secretary Xavier Beccera noted that such a decision undermines the Food and Drug Administration’s authority to approve therapeutics. Beccera said that the decision could let judges make the final call on whether drugs are approved, which may be weaponized against politically polarized drugs like COVID vaccines or new Alzheimer’s drugs.
Washington Judge Rules FDA Cannot Rollback Abortion Pill Access
The same day that a Texas judge issued a ruling invalidating the US Food and Drug Administration’s (FDA’s) decades long approval of mifepristone, a key component of the abortion pill, a federal judge in Washington state ruled that the FDA may not roll back access to the drug in 17 states. The ruling , delivered by US District Court Judge Thomas Rice, is in direct opposition by the nationwide ruling issued in Texas.
US Democrats Prepare Bill to Combat Abortion Pill Ruling
In response to a ruling by US District Court Judge Matthew Kacsmaryk that invalidated the 20-year-old approval of mifepristone, a key component of the abortion pill, US House Democrats have begun preparing a bill that would codify the agency’s right to approve the drug. The bill, which will likely face stiff resistance from the Republican House majority, was announced by representatives Pat Ryan (D-NY) and Lizzie Fletcher (D-Texas).
Texas Judge Cancels FDA Approval of Key Abortion Pill Component
US District Court Judge Matthew Kacsmaryk issued a ruling invalidating the decades-old approval of a key component of the most common form of abortion pill in the US, mifepristone. The ruling, which fell in favor of anti-abortion activists, ends not only the initial approval by the US Food and Drug Administration (FDA) but also recent policies meant to expand access to the drug. The move, some lawmakers, abortion rights advocates, and legal experts content, would undermine the agency’s independence.
NHS to Cover Lynparza for Breast and Prostate Cancer
Shortly after a recommendation from the UK’s National Institute for Care and Health Excellence (NICE), the NHS agreed to provide Lynparza, Merck and AstraZeneca’s prostate and breast cancer drug, to patients in Wales and England. The move comes after positive results showing the drug lowered mortality in breast cancer patients by a third.
US Senators Looking to Make Changes to Upcoming Legislation on Generics and PBMs
US Senators Bernie Sanders (I-VT) and Bill Cassidy (R-LA) are looking to April 19th when they can start deliberating on changes to an upcoming piece of legislation about generic drugs and the pharmacy benefit manager (PBM) industry. The bipartisan effort comes after increasing public and congressional pressure on PBMs and drug prices.
Novo Nordisk’s Wegovy Nabs CHMP Recommendation for Use in Teens
The European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) has recommended the Novo Nordisk weight-loss medication Wegovy (semaglutide) for use in adolescents 12 and up. The move comes after a phase 3 trial showed the drug to be effective teens, with almost 3/4ths of participants losing 5% of their body weight.
EU Preps for Drug Law Overhaul
The EU is preparing legislation that would overhaul the pharmaceutical industry with a series of reforms targeting drug prices, transparency, and intellectual property (IP). Under the legislation, drugmakers would have a reduced exclusivity period for new drugs, which can be ameliorated by launching a drug in all member states simultaneously. In addition, the laws would simplify the regulatory approval process.
CMS Trims Down List of Drugs Targeted for Price Hike Penalties
The US Centers for Medicare and Medicaid Services (CMS) has pulled 7 drugs from its list of medicines facing penalties for drug price hikes. The Inflation Reduction Act included a provision that would penalize drug manufacturers for raising the price of drugs faster than inflation. This brings the total down to 20 drugs.
European Commission Approves BMS’ New Plaque Psoriasis Drug
Bristol Meyer Squib (BMS) has scored a win with the European Commission (EC) approval of Sotyktu, its new treatment for plaque psoriasis. The treatment would be the first of its kind, an oral allosteric tyrosine kinase inhibitor. The approval covers adults with moderate-to-severe psoriasis that may benefit from systemic treatment for the disease.
NICE Issues Final Draft Guidance Recommending Tezspire for Severe Asthma
The UK’s National Institute for Health and Care Excellence (NICE) released a final draft guidance recommending the use of Amgen and Astrazeneca’s Tezspire in maintenance treatment for some patients with severe asthma. The biologic is the only one of its kind, targeting an important asthma-related inflammatory protein.
Narcan Goes OTC in the US
The US Food and Drug Administration (FDA) has approved over-the-counter (OTC) sales of Narcan (naloxone), a drug used to immediately treat an opioid overdose. The drug could previously be prescribed and sold at many pharmacies, but the OTC designation should expand the reach of the drug to more pharmacies and people who may use the drug on others.
Three Major FDA Adcomms on the Horizon
As May approaches, the US Food and Drug Administration (FDA) is planning for three advisory committees that have major implications for healthcare in the US. The first will review Perrigo’s over-the-counter contraceptive. Next, a committee will examine an intranasal epinephrine spray for severe asthma. The final will focus on a yet unnamed product from Intarcia Therapeutics.
Blueprint’s Experimental Cancer Drug Back in the Clinic After FDA Hold Lifted
New patients will receive Blueprint Medicine’s experimental cancer drug BLU-222 after the US Food and Drug Administration (FDA) lifted a partial hold. The agency paused dosing new patients after some participants reported vision-related adverse events. Blueprint said its updates to its protocols on adverse events were responsible for the hold being lifted.
England’s Cancer Drugs Fund to Provide Keytruda for Cervical Cancer
After a recommendation from the UK’s National Institute for Health and Care Excellence (NICE), England’s Cancer Drugs Fund (CDF) announced it will cover Merck’s (MSD in the UK) Keytruda for patients living with advanced metastatic cervical cancer. This opens up a new avenue of treatment for the thousands of women diagnosed with the disease in England each year.
Amgen Facing Stiff Resistance in US Supreme Court Patent Case
Amgen’s odds with the US Supreme Court are looking grim in its case against Sanofi-Regeneron regarding its “genus patent” over antibody-based PCSK9 inhibitors. Amgen maintains its patent covers a wide group of antibodies for the drug target and should be expanded to cover all possible permutations. Sanofi’s lawyers argue this extension would be far too broad, with the Justices seeming to agree.
US FDA Releases Draft Guidance on Oncology Clinical Trials Seeking Accelerated Approval
In a new draft guidance, the US FDA proposes two strategies to make clinical trials for cancer drugs better support accelerated approval applications for cancer drugs. Such applications are expected to be followed by confirmatory studies that often don’t materialize or yield negative results. The first suggestion is to move to a single trial for accelerated approval that also confirms potential health benefits.
Patient Advocacy Groups Decry NIH Refusing to Exert March-In Rights for Prostate Cancer Drug Xtandi
Patient advocacy groups are speaking out after the US National Institutes of Health (NIH) decided against exercising march-in rights, which allows the government to share patents developed with public funds, on Pfizer’s and Astella’s prostate drug Xtandi. The move would’ve lowered prices for the drug, but the agency ruled that the effort involved was not justified based on the remaining length of the patent.
