Monday, May 19, 2025

Biocon Biologics Plans To Slow Down After Five Planned Near-Term Biosimilar Launches

(5/16, Urte Fultinaviciute, Generics Bulletin) ...The biosimilars segment contributed significantly to company revenues, delivering 54% of earnings this quarter. Ustekinumab biosimilar is projected to have a strong impact, having secured access for over 100 million lives, although specific market share details were not disclosed. In the insulin sector, Biocon is expanding its manufacturing capabilities and has partnered with Civica to enhance market reach... Global Sub. Full

Marksans Pharma Arm Receives Regulatory Approval for Sennosides Tablets, Shares Gain 6%

(5/19, Shloka Badkar, CNBC TV-18) ...Shares of Marksans Pharma gained over 6% on Monday, May 19, as the company said its wholly-owned subsidiary Relonchem Limited in the United Kingdom received market authorisation for Sennosides 7.5 mg tablets from the UK Medicines and Healthcare Products Regulatory Agency. The Sennosides tablets are used to treat constipation as per the US government's MedlinePlus website... Full

Weighing Approval Bids from J&J, Pfizer and Roche, FDA Scrutinizes Data Ahead of Adcomm

(5/16, Angus Liu, Fierce Pharma) ...For an upcoming oncology advisory committee meeting, the FDA is questioning whether Johnson & Johnson, Pfizer and Roche have provided convincing clinical data for their cancer drugs in the right patient populations... Full

Amarin Calls Hikma's Drug Label Arguments 'Idiosyncratic,' Urges High Court to Decline Case

(5/16, Alexis Kramer, Endpoints News) ...Amarin is pushing back on Hikma's petition to rehear a federal court decision that revived Amarin's patent lawsuit against the generic drugmaker. Amarin claimed that Hikma induced physicians to prescribe a generic version of its drug Vascepa for an infringing use, even though Hikma left Amarin's patented indication off the generic's label. The dispute involves a common practice known as "skinny labeling" that generics makers say helps them bring more low-cost drugs to the market. But the two companies disagree on how much this case would impact that practice... Sub. Req’d

Acadia Wins Patent Ruling Over Aurobindo's Nuplazid Copies

(5/16, Christopher Yasiejko, Bloomberg Law) ...Acadia convinced Judge Gregory B. Williams that Aurobindo's generic pimavanserin capsules infringe US Patent No. 11,452,721 and Aurobindo failed to prove the patent's claims are invalid, according to an order in the US District Court for the District of Delaware. Williams issued an opinion explaining his reasoning under seal, which comes after a December bench trial... Sub. Req’d

Bucks County Officials Announce Lawsuit Accusing Drug Giants of ‘Illegal Price Fixing' for Insulin

(5/17, Jesse Bunch, The Philadelphia Inquirer) ...The lawsuit, filed in U.S. District Court in the District of New Jersey, alleges that Bucks County, which offers health coverage to its more than 2,000 employees, pays excessively high prices for insulin and other diabetes medications. Pharmacy benefit managers CVS Caremark, Express Scripts, and OptumRx are listed as defendants, as are insulin manufacturers Eli Lilly and Co., Novo Nordisk, and Sanofi... Full

Dr Reddy's Gets 2 Observations from USFDA for New York API Plant

(5/17, Press Trust Of India) ...Dr Reddy's Laboratories on Saturday said the US health regulator has issued a Form 483 with two observations after inspecting its US-based facility. The US Food and Drug Administration completed a Good Manufacturing Practice inspection at the company's API (active pharmaceutical ingredients) Middleburgh facility in New York, Dr Reddy's said in a regulatory filing... Full

Ozempic Knockoffs Survive Crackdown Thanks to Loophole

(5/18, Alex Janin, The Wall Street Journal) ...They are making and selling dosages slightly different from the standard, FDA-approved amounts or including additives such as vitamins B3 and B12. Others have changed how the drug is taken, switching from injectables to under the tongue drops or pills. These providers are relying on a law that allows bespoke versions of drugs that are unavailable commercially. Though some patients report delays in receiving the compounded medications, many are still getting them—at least for now—said patients and industry professionals... Sub. Req’d

GLP-1 Weight-Loss Drugs are Revolutionary – and They're Exposing America's Healthcare Crisis

(5/16, David A Kessler, The Guardian) ...The pharmaceutical industry is charging too much for these drugs. The FDA is becoming dismantled under the current administration and is not capable of assuring the safety of drugs coming into this country. The health insurance industry has made it impossible to get access to these drugs. The American public is only going to grow angrier. No American should have to worry about whether their insurance coverage is enough to keep them alive or provide access to the medicines they need... Full

Resetting the Walk-Away Price: How GoodRx Data Reveals New Realities of Prescription Abandonment

(5/16, Adam J. Fein, Ph.D., Drug Channels) ...Our healthcare system has a persistent challenge: patients abandoning prescriptions at the pharmacy counter. While several factors contribute to this, none are as influential—or possibly as solvable—as patient out-of-pocket (OOP) costs. New data from pharma-sponsored cash buydown programs with GoodRx show a wide range of OOPs at prices well above a historical "walk-away" price of $50 (range is $65 - $231) significantly reduced reversal rates across specialties including asthma, birth control, diabetes, and high cholesterol... Full

HHS, DARPA Link Up with Rutgers, Cost Plus Drugs and Others in Initiative to Rethink US Drug Production

(5/16, Fraiser Kansteiner, Fierce Pharma) ...The project, dubbed Equip-A-Pharma, will allow the federal agencies to work directly with Battelle Memorial Institute and Aprecia, Bright Path Laboratories, Rutgers University and Mark Cuban's Cost Plus Drugs as the partners strive to boost domestic manufacturing of eight drugs and their active pharmaceutical ingredients, the ASPR said in a Thursday press release. Incorporating emerging technologies like AI in the drug production process has the potential to boost manufacturing efficiency, lower costs, curb drug shortages and speed approval timelines, the ASPR said... Full

Mark Cuban Compounder Joins Trump's New Manufacturing Initiative

(5/16, Anna Brown, Endpoints News) ...Cost Plus Drugs will use an AI-based manufacturing platform to make the anesthetic lidocaine and the calcium channel blocker diltiazem. Meanwhile, the nonprofit Battelle Memorial Institute and pharma company Aprecia will create 3D-printed tablets of the epilepsy treatment levetiracetam and the antimicrobial drug linezolid, which is used to treat infections like bacterial pneumonia... Sub. Req’d

The Trump Administration's Drug Price Actions and Why US Prices Are Already Sky-High

(5/17, Skylar Jeremias, The Center for Biosimilars) ...As efforts to address high drug prices continue to evolve, the introduction of pharmaceutical tariffs adds a new layer of complexity to an already fragmented system. Proponents argue tariffs could protect domestic production and level global pricing, but critics warn they may disrupt supply chains and drive costs even higher. As the policy landscape shifts once again, it remains unclear whether tariffs will serve as a meaningful solution—or simply another variable in a system still searching for balance... Full

Q&A On Trump's Prescription Drug Pricing Executive Order

(5/16, Catalina Jaramillo and Kate Yandell, Roll Call) ...Past analyses have predicted that "most favored nation" pricing models would likely run into various practical challenges, such as efforts by drug companies to obscure how much foreign countries were truly paying for drugs, or companies pulling out of supplying certain drugs to other countries entirely. "How this executive order will translate into lower prices that patients in the U.S. will pay for prescription drugs is pretty unclear," Juliette Cubanski, deputy director of the program on Medicare policy at the health policy research group KFF, told FactCheck.org. Here we answer questions about drug prices in the U.S. versus internationally, and about the potential implications of the executive order... Full

Draft Guidance For Third Negotiation Cycle Ushers In Part B Drugs & Renegotiation

(5/16, Gabrielle Wanneh, Inside Health Policy) ...The latest draft guidance for Medicare drug price negotiations clarifies that a drug company's introduction of a fixed combination drug with an altered formulation and delivery method can no longer reset the timeline for when the original drug is eligible for negotiation, closing a loophole in previous guidance that sources say could have allowed Merck and Bristol Myers Squibb to seek protections for their subcutaneous versions of Part B cancer treatments Keytruda and Opdivo... Sub. Req’d

HHS Scores Partial Win in Fight of Drugmakers' Rebate Model

(4/16, Nyah Phengsitthy, Bloomberg Law) ...A federal judge partly sided with HHS over its decision to not approve proposals from Bristol Myers Squibb Co., Novartis AG, Eli Lilly & Co., and Sanofi SA that would dramatically change how they discount medicines to providers that treat lower-income and uninsured patients. Judge Dabney L. Friedrich of the US District Court for the District of Columbia ruled the US Health Resources and Services Administration didn't act illegally when it denied bids from the drugmakers to discount medicines through a rebate model rather than up front to covered entities under the federal 340B Drug Pricing Program... Sub. Req’d

HHS Can Require Approval for Drugmakers to Apply 340B Rebate Models, Court Rules

(5/16, Nicole DeFeudis, Endpoints News) ...The plaintiffs, Eli Lilly, Novartis, Bristol Myers Squibb and Sanofi, have argued that the 340B program is abused and introduced plans that would require hospitals to purchase 340B-eligible drugs at market price and recoup the discounts via rebates, as opposed to upfront. They claimed that HRSA erred by barring implementation of those plans without prior agency approval... Sub. Req’d

‘We Can't Keep Going On Like This' – Biosimilars Forum's Reed Calls For Urgent Changes In US

(5/16, Dave Wallace, Generics Bulletin) ...Biosimilars Forum executive director Julie Reed has set out her vision of the current state of the US biosimilars industry. Reed is calling for changes to the way biosimilars are reviewed at the FDA, the elimination of unnecessary three-way PK studies, and dropping four-letter suffixes for biologic names. She also voiced her support for certain priorities of the new Trump administration, while acknowledging concerns over FDA upheaval and potential pharma tariffs... Global Sub. Full

US FDA Legislative Lead Calls For User Fee Reforms As Renewal Talks Near

(5/17, Sarah Karlin-Smith, Pink Sheet) ...FDA Deputy Commissioner Grace Graham supports user fees, but said the process needs reform to minimize the perception that the agency and industry are too close. Graham also suggested domestic manufacturers may need to pay increased fees to have domestic factories ready more quickly. Graham also told the FDLI annual conference that ensuring drugs are used according to their evidence base is part of the MAHA agenda... Global Sub. Full

Deputy FDA Chief Mulls Shaking Up PDUFA Reauthorization Structure

(5/16, Zachary Brennan, Endpoints News) ..."As we look towards the next reauthorization, it is time to take a step back and think about if the fee structures and amounts have any unintended consequences," Grace Graham, the FDA's deputy commissioner for policy, legislation and international affairs, told the Food and Drug Law Institute's annual conference. Graham noted that user fees are crucial for the FDA and make up a significant share of agency funding. About 70% of the FDA's drug center budget is made up of industry funds... Sub. Req’d

US FDA Guidance Roadblock: Writing Continues, But Publication Has Slowed Or Stopped

(5/16, Derrick Gingery, Generics Bulletin) ...FDA reviewers and scientists continue to write guidances, but publication has slowed substantially since the Trump Administration took office. Product-specific guidances, used for generic drug development, have not been published since November, in part because of cuts to the policy staff in the Office of Generic Drugs. Sponsors are concerned that multiple publication deadlines could be missed because of the cuts... Global Sub. Full

Califf In Conversation: ‘Decimated' US FDA Teams Endanger Innovation

(5/16, Barnaby Pickering, Pink Sheet) ...The sudden reduction in the FDA workforce, particularly among supporting teams and specialized experts, has undermined the collaborative environment needed for thorough regulatory reviews and is already delaying drug approvals. Califf warned that current policies could make vaccine development financially unviable for pharmaceutical companies, while the "decimation" of the biologics center threatens progress for rare disease patients at a time when breakthrough treatments were on the horizon... Global Sub. Full

Auchincloss: FDA Needs Bipartisan ‘Top Cover' To Prevent Kennedy, Means, DOGE Meddling

(5/16, Luke Zarzecki, Inside Health Policy) ...Speaking at the Food and Drug Law Institute's Friday (May 16) conference, Auchincloss described HHS special employee Calley Means, former Director of the Center for Medicare & Medicaid Innovation Brad Smith, who is now working with the Department of Government Efficiency, and HHS Secretary Robert F. Kennedy Jr. as conspiracy theorists working to draw unscientific links between vaccines and autism. He alleged they are undermining the Vaccine Injury Compensation Program and could turn the biopharmaceutical industry into "one giant GNC store."... Sub. Req’d

FDA Working To Streamline State Drug Importation Reviews

(5/16, Luke Zarzecki, Inside Health Policy) ...FDA is working to streamline its review of state drug importation applications and make it easier for states to obtain authorization, after President Donald Trump signed an executive order Monday (May 12) calling for FDA to expand use of drug importation programs, including beyond Canada... Sub. Req’d

Trump Wants to ‘Equalize' and Lower Drug Prices. Could Canada Be Impacted?

(5/17, Sean Boynton, Global News) ...In Canada, drug prices are overseen by the Patented Medicine Prices Review Board, which told Global News it protects Canadian consumers by reviewing prices and ensuring they're not "excessive."...Health Canada says it has been "taking all necessary action to safeguard the drug supply and ensure Canadians have access to the prescription drugs they need" ever since the Florida program was approved. A spokesperson said the department has reminded drugmakers and exporters of its obligations under Canada's Food and Drug Regulations, which prohibits the sale of certain drugs intended for the Canadian market outside Canada "if that sale would cause or worsen a drug shortage in Canada."... Full

Euro Convergence: Officials Discuss AI in Regulatory, Hope Pharma Legislation Will Streamline Combo Product Review

(5/16, Ferdous Al-Faruque, Regulatory Focus) ...Officials said their organizations are evaluating the use of artificial intelligence (AI) for regulatory purposes but cautioned that the technology is still prone to errors, and that human review is needed to ensure accuracy. They also expressed hope that the EU pharmaceutical legislation will provide a streamlined pathway for combination products... Full

Medicines for Poland: Europe Faces a Critical Choice on Medicines and Market Reform

(5/16, Medicines for Poland) ...Member States are nearing the end of discussions on EU pharmaceutical reform to ensure affordable medicines and support EU manufacturing in Europe. This will enhance the Union's strategic resilience and autonomy, promote economic growth, and strengthen the sustainability of national healthcare systems. Europe is facing shortages of medicines, with dependence on the supply of key pharmaceutical ingredients from Asia reaching 80%. Restoring essential medicine production is vital to Europe's strategic resilience and economic growth. Given current geopolitical tensions and financial pressure linked to expanding the EU's defence capabilities, it is essential to foster pharmaceutical market competition to help reduce healthcare spending... Full

John Whelan: Ireland Needs a EU-US Trade Deal to Protect Pharma

(5/18, Irish Examiner) ...The recent rapid rise in US imports of pharmaceuticals from Ireland and across the EU has exacerbated the issue for Mr Trump...In an attempt to get around the conundrum, Mr Trump last week vowed to force European countries to pay higher drug prices while squeezing pharmaceutical companies to cut prices for US consumers by up to 80%. Ireland, which relies heavily on its pharmaceutical exports to the US, will be worried by his threat his administration would punish countries who refused to equalise their medicines with those in the US or extort US drug companies into lowering their charges in their own countries... Full

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