Pharma Already Bristling at Parts of EU Drug Overhaul
As the EU preps for a massive pharma regulation overhaul, industry groups have already begun levelling complaints. The reforms include simplifying the approval process, cutting approval timelines, and reducing exclusivity periods from 10 years to 8 years for new drugs, the key sticking point for pharma companies.
FDA Panel Votes for Limited Approval of AstraZeneca and Merck’s Lynparza
AstraZeneca and Merck’s Lynparza looks set for a narrow approval as part of a combination therapy for metastatic castration-resistant prostate cancer (mCRPC). In an 11 to 1 vote, a Food and Drug Administration (FDA) panel supported approval of the drug in combination with a corticosteroid and J&J’s Zytiga only for a small subset of mCRPC patients.
Positive Phase 3 Trial Results Set Up Lilly’s Mounjaro for Potential Approval This Year
Eli Lilly just wrapped up its SURMOUNT-2 phase 3 trial for Mounjaro (tirzepatide), with results showing that the drug successfully helped patients with Type 2 diabetes lose weight. Patients taking a 15 mg maintenance dose lost 15.7% of their body weight while those taking a lower dose lost 13.4%, significantly higher than the 3.2% lost by those given placebo.
European Commission Reveals Plans for Single Market
Despite having region-level drug approval agencies like the European Medicines Agency (EMA), member states have their own approval agencies. This fragmented framework slows the rollout of new pharmaceuticals. To address this issue, the European Commission has released their plans to unify the approval process across all member states.
Biogen Wins FDA Accelerated Approval for Rare ALS Treatment
The US Food and Drug Administration (FDA) issued an accelerated approval for Biogen’s drug Qalsody, a treatment for a rare form of amyotrophic lateral sclerosis (ALS). The decision was based on data that showed that the drug reduced levels of a key neurodegeneration marker by 55% at the 28-week time point.
US Democrats Introduce Bill to Expand Medicare Prescription Drug Price Negotiations
A group of 21 US Democrats introduced a new bill that seeks to strengthen the upcoming Medicare pricing negotiations with the Centers for Medicare and Medicaid Services (CMS) instantiated by the Inflation Reduction Act. The bill, if passed, would shorten the timeframe for drug pricing negotiations to begin to 5 years, a significant departure from the 9 years currently established for small molecule drugs and the 13 years set for biologics.
The Fight Between Pharma and CMS Over Drug Pricing Reform Has Only Just Begun
Despite efforts by the pharma industry to stop it, Medicare prescription drug pricing negotiations from the US Inflation Reduction act still loom on the horizon. As a result, the industry is shifting its approach, now focusing on changing the law to its favor. Although pharma is putting energy into lobbying, litigation is soon to come.
AHIP Launches Campaign Tearing into Pharma for Drug Prices
AHIP, representing members of the US health insurance industry, is targeting pharma in its latest ad campaign. The campaign lays the blame for high prescription drug prices at pharma’s feet, highlighting anti-competitive practices, unjustified price hikes, and high profit margins for the largest pharmaceutical companies. However, pharma argues that payers themselves contribute to the problem.
Generics Group Wants in On UK Voluntary Scheme Negotiations
Around 40% of drugs covered by the UK’s voluntary drug revenue rebate system, the Voluntary Scheme for Branded Medicines Pricing and Access (VPAS), are generics and biosimilars. Because of this, the British Generics Manufacturers Association (BGMA) wants in on deliberations just like the organization representing branded medications, the Association of the British Pharmaceutical Industry (ABPI).
Relentless Health Value Podcast: Talking Medicare Drug Pricing Negotiations with Dr. Peter Neumann
In the latest episode of the Relentless Health Value podcast, host Stacey Richter sits down with Peter Neumann, ScD, of the Center for the Evaluation of Value and Risk in Health (CEVR) at Tufts University to discuss upcoming Medicare drug pricing negotiations. The two discuss how pricing negotiations will account for value and what effects they will have on drug prices for patients.
NICE Approves Combo Therapy for Leukemia by J&J and Abbvie
The UK’s National Institute of Health and Care Excellence (NICE) has issued its approval of J&J and Abbvie’s combination therapy of Imbruvica and Venclyxto for use as a first-line treatment of chronic lymphocytic leukemia (CLL). The combo will be released as a pill taken once per day, the first of its kind for a CLL chemotherapy drug.
PhRMA Not a Fan of CMS Drug Price Negotiation Plans
Just as the US Centers for Medicare and Medicaid Services (CMS) closed its public comments for the initial draft guidance for its upcoming Medicare drug price negotiations process, the pharma industry group PhRMA has laid out its complaints in a 76-page letter delivered last week. The comment window, only one month long, was a sticking point for the group.
US Senate Finance Committee Unveils Plan to Regulate PBMs
A group of US senators in the Senate Finance Committee have released their plan to implement regulation targeting the pharmacy benefit manager (PBM) industry. The plan proposes changing how PBMs get compensated for drug sales, increasing transparency, and holding them financially and legally accountable for violations.
FDA Approves Polivy as First-Line Lymphoma Treatment
Roche has scored a win with the US Food and Drug Administration’s (FDA’s) approval of its drug Polivy for front-line diffuse large B-cell lymphoma (DLBCL). The approval comes after some reviewers were concerned about the benefits of the drug over the standard of care based on results from the phase III POLARIX study.
Examining Why Major Insulin Manufacturers Dropped Insulin Prices
In the months following the US Inflation Reduction Act capping the price of insulin for Medicare recipients, three of the largest insulin manufacturers cut their prices for the drug. Leemore Dafny, PhD, broke down why the pharma giants made this decision. One key reason put forward by Dafny was the concept of corporate shaming.
US Supreme Court Extends Mifepristone Access Temporarily with 2-Day Pause on Lower Court Ruling
The US Supreme Court has issued a 2-day pause on a lower ruling that would revoke the decades-old approval of mifepristone, a key component of the abortion pill. The stay would end at midnight this Friday, April 21st. The ruling has drawn substantial criticism, not the least of which is that allowing a judge to overturn approval by the US Food and Drug Administration (FDA) would undermine the agency’s authority to regulate medications.
PhRMA Calls Foul on CMS Policy to Destroy Documents After Price Negotiations
The latest guidance from the US Centers for Medicare and Medicaid Services (CMS) contains a clause that states that manufacturers must destroy all documents from the agency within 30 days after a therapeutic is no longer considered a selected drug. PhRMA, a major industry group, claims this practice is unconstitutional and overreaching, making the process less transparent.
Patient Recruitment Dodges Older Adults to Their Detriment
Despite representing the largest market for new and existing medications, a recent study by the UK-based International Longevity Centre (ILC) finds that adults over 60 are starkly underrepresented or outright excluded from clinical trials. Costs are commonly credited for this disparity, which imperils health outcomes for older adults.
FDA Advisory Committee Recommends Rexulti for Alzheimer’s-Related Agitation
Agitation is a common symptom of Alzheimer’s disease, negatively impacting the quality of life for patients and their caregivers. An advisory committee for the US Food and Drug Administration (FDA) has given the nod to expand the indication of Takeda and Lundbeck’s Rexulti, a widely used atypical antipsychotic, to include the treatment Alzheimer’s disease-related agitation (AAD).
Making Naloxone OTC Doesn’t Go Far Enough
Last month, the US Food and Drug Administration (FDA) approved the over-the-counter (OTC) sale of naloxone, a drug commonly known as Narcan that reverses opioid overdoses instantly. The move was hailed by patient advocates, but many feel that OTC access is not enough to get the drug in the hands of those who need it. One key sticking point is the high cost per dose for name brand Narcan.
US Supreme Court Pauses Texas Judge’s Ruling to Revoke FDA Approval of Mifepristone
Following calls to act on a ruling from a Texas federal judge that would overturn the US Food and Drug Administration’s (FDA’s) approval of the abortion drug mifepristone, the Supreme Court has stepped in and placed a 5-day hold on the lower court’s decision. The temporary stay will last until Wednesday, April 19th.
US FDA Shoots Down Eli Lilly’s Application for Ulcerative Colitis Drug
The US Food and Drug Administration (FDA) has declined to approve Eli Lilly’s ulcerative colitis drug mirikuzimab. The agency credits manufacturing issues for the decision, noting that the drugs efficacy and safety are not in question. A Lilly spokesperson said that they are working closely with the agency to address these problems and bring the drug to market.
Public Comments Closing for Medicare Drug Pricing Negotiations
As the window for public comments on the US Centers for Medicare and Medicaid Services’ (CMS’s) plan to negotiate Medicare drug prices comes to a close, Republican lawmakers and pharmaceutical companies seem to be in agreement with their complaints. A group of congress members from both the Senate and House argue that the plan will hurt patients, providers, and caregivers if implemented.
Danco Laboratories and DOJ ask for US Supreme Court Action on Conflicting Mifepristone Rulings
Both the US Department of Justice (DOJ) and the mifepristone distributor Danco Laboratories have called upon the US Supreme Court to act quickly to hold back the effects of dueling federal court cases regarding the drug. The Fifth Circuit Court of Appeals temporarily paused last week’s ruling that mifepristone, a key drug used in the abortion pill, was inappropriately approved. Although mifepristone can stay on the market for now, expanded access to the drug would be cut, putting manufacturers and the FDA in conflict with another ruling last Friday.
US Appeals Court Temporarily Blocks Decision to Strike Down Mifepristone Approval
The US Fifth Circuit of Appeals issued a ruling that temporarily blocks last week’s federal court ruling overturning the approval of mifepristone, a key component for the abortion pill. The pause is temporary, and it may require the US Food and Drug Administration (FDA) to revert to previous rules regarding its distribution.
