Thursday, June 5, 2025

Alvotech and Dr. Reddy's Collaborate to Co-develop Oncology Biosimilar Candidate

(6/5, Pharmabiz.com) ...Under the terms of the agreement, the parties will be jointly responsible for developing and manufacturing the biosimilar candidate and sharing costs and responsibilities. Subject to certain exceptions, each party will have the right to commercialize the product globally... Full

Amneal Pharmaceuticals Issues Recall Due to Microbial Contamination

(6/4, Kelly Cloonan, Dow Jones) ...Amneal Pharmaceuticals has recalled three lots of sulfamethoxazole and trimethoprim tablets that have black spots on their surface due to microbial contamination. The company said it has received no reports of adverse events, illnesses or injuries related to defective products. Products contaminated with Aspergillus, a fungus, could result in serious and life-threatening infections, especially in patients with underlying immunosuppressive conditions, the company said... Full

Glenmark Adamant FDA Monroe Site Reinspection Could Happen ‘Any Time'

(6/5, Dean Rudge, Generics Bulletin) ...The US Food and Drug Administration should return "pretty soon" to inspect Glenmark's key injectables manufacturing facility in Monroe, North Carolina, according to the Indian firm, which continues to be frustrated in its efforts to push through filings amid a concerted pivot to complex products in the US... Global Sub. Full

Shilpa Stumbles On Lenvima Challenge And Faces Wait Until 2036

(6/4, Dean Rudge, Generics Bulletin) ...The Indian firm has failed in an attack on Eisai's US patent 11,186,547, which covers "highly pure lenvatinib mesylate as found in the company's Lenvima product," according to an oral decision hearing from US District Court for the District of New Jersey judge Christine O'Hearn... Global Sub. Full

Itochu Working to Support Overseas Pharma Firms to Fill Japan's Drug Gaps

(6/5, Koh Yoshida and Kanoko Matsuyama, Bloomberg) ...Two Itochu units are expanding into the business of attracting more foreign drug companies to Japan, in a bid to help them develop innovative therapies for the local market that are already available overseas... Sub. Req’d

Vigil's Rare Brain Disease Drug Flunks Phase 2 Study, but Sanofi Takeover Is Unaffected

(6/4, Nick Paul Taylor, Fierce Pharma) ...Sanofi struck a deal to buy Vigil for $470 million last month but opted against taking ownership of iluzanebart as part of the takeover. Rather, Vigil agreed to return the rights to iluzanebart to Amgen and allow Sanofi to focus on the small-molecule TREM2 agonist VG-3927. At the time, William Blair analysts expressed doubt that Vigil would have agreed to the terms if iluzanebart data were "clearly promising."... Full

Novo Nordisk Signs on to Support ADA's Obesity Advocacy Division

(6/4, Andrea Park, Fierce Pharma) ...Now, Novo Nordisk is joining the cause. The Danish drugmaker, which sells GLP-1 blockbuster Wegovy and its predecessor Saxenda for obesity, will provide an undisclosed amount of funding in a "multi-year commitment," per an ADA announcement this week. In addition to monetary support, the ADA said it's also working with Novo to "explore further opportunities" to boost awareness and education and find "innovative solutions" to improve obesity care uptake... Full

AstraZeneca CEO Suggests Cause Behind High Drug Prices

(6/4, Fox Business) ...AstraZeneca CEO Pascal Soriot unpacks President Donald Trump's drug cost cut executive order on 'The Claman Countdown.'... Full

Biotech CEO Confidence Hits Rock Bottom Amid Policy Shifts

(6/4, Meagan Parrish, PharmaVoice) ...Almost all — 92% — expressed concern that investors are moving out of biopharma for lower-risk industries amid policy changes and uncertainty. The rock-bottom level of confidence was no surprise to John Stanford, executive director at Incubate. "When 9 in 10 CEOs say their investors seem more interested in other sectors, that's a very honest reaction that fits with the anecdotes I've gotten from leaders," he said... Full

Pharmaceutical Tariffs Could Threaten Global Drug Supply Chains

(6/4, Logan Lutton, Managed Healthcare Executive) ...The tariffs could impact generic drug production, many of which are made in India and China. However, the real concern is shortages of more essential medications, according to Eric Tichy, Pharm.D., M.B.A., vice chair of pharmacy formulary at the Mayo Clinic Health System. Tichy recently published a study on projected U.S. drug expenditures for 2025... Full

The National Security Stakes of Pharmaceutical Tariffs

(6/4, Soumi Saha, Mark Hendrickson, MedCity News) ...While the thoughtful and targeted use of tariffs can boost supply chain resiliency in the long-term, material increases in tariffs on pharmaceuticals coupled with rapid implementation timelines can result in unintended consequences that increase costs and shortages in the short-term. Any unified trade policy on pharmaceuticals must ensure that overarching supply chain resiliency goals are met while minimizing the downstream impact to patient care... Full

Lee Bill Cuts Drug Prices and Red Tape

(6/4, U.S. Senator Mike Lee (R-UT) ...U.S. Senator Mike Lee (R-UT) introduced the bipartisan Biosimilar Red Tape Elimination Act today to cut drug prices for consumers and increase competition in the pharmaceutical market by categorizing generic-brand "biosimilar" drugs as interchangeable with their name-brand counterparts. Senators Rand Paul (R-KY), Maggie Hassan (D-NH), and Ben Ray Luján (D-NM) cosponsored the legislation... Full

Medicare Negotiations Underway to Lower Prices for Next Batch of Drugs

(6/4, Sydney Lupkin, NPR Shots) ...Two companies – Novo Nordisk and Amgen – confirmed to NPR that they had received opening price offers from the government, kicking off bargaining that could last through October. The Department of Health and Human Services did not respond to a request for comment on the status of negotiations... Full

FDA to Meet Drug Approval Goals Despite Cuts, Commissioner Says

(6/4, Damian Garde, Bloomberg) ...The FDA "will have no problem" approving new drugs on time, Marty Makary said at a Jefferies investor conference Wednesday. "That is the top priority at the agency." The staffing cuts didn't affect any scientific reviewers or inspectors, he said... Sub. Req’d

Asthma Sufferers Could Be at Greater Risk If Trump Cuts Health Program

(6/5, Miranda Green, CBS News) ...In May, the White House released a budget proposal that would permanently shutter the Centers for Disease Control and Prevention's National Asthma Control Program, which was already gutted by federal health department layoffs in April. It's unclear whether Congress will approve the closure. Last year, the program allotted $33.5 million to state-administered initiatives in 27 states, Puerto Rico, and Washington, D.C., to help communities with asthma education. The funding is distributed in four-year grant cycles, during which the programs receive up to $725,000 each annually... Full

India's Drug Regulator Plans Overhaul of Schedule H for Prescription Medicines

(6/4, Priyanka Sharma, Mint) ...Drugs Controller General of India (DCGI), the country's top drug regulator, is planning a complete overhaul of medicines listed under Schedule H of the Drugs and Cosmetics Rules, 1945, which governs the sale of prescription drugs, said an official aware of the matter and documents reviewed by Mint. The proposed revamp is driven by concerns, including a rise in antimicrobial resistance (AMR) from self-medication and rampant use of antibiotics purchased over the counter without prescription, the official said... Full

Medicines for Europe Calls for Balanced Safeguards on Access to Medicines in EU Water Resilience Strategy

(6/4, Medicines for Europe) ...Available data clearly show that this scheme, introduced to finance quaternary treatment for residues from human consumption, will undermine patient access to medicines for diabetes, cardiovascular disease, epilepsy, and infections...The implementation of EPR needs to be paused while this assessment is conducted and a more effective and balanced solution must be found urgently, in line with the concerns expressed by 16 Member States and recently by the European Parliament... Full

EU Pharma Reform Package Clears Big Political Hurdle After Council Adopts Position

(6/4, Neena Brizmohun, Pink Sheet) ...The council said on 4 June that it was "now ready to begin negotiations with the European Parliament with a view to reaching an agreement on the package. The new rules will then be adopted following legal-linguistic revision." Legal experts have predicted that a final agreement may not be reached until 2026, and that its provisions might not actually be implemented until 2028... Global Sub. Full

Council Agreement on Review of EU Pharmaceutical Legislation

(6/4, Medicines for Europe) ...Medicines for Europe supports this reform provided it can truly deliver on equitable access to medicines for all Europeans and it contributes to increasing the security of supply of medicines. We will oppose attempts to extend incentives and intellectual property rights which are already provide the longest monopoly protections in the world. We urge the Council, Parliament and Commission to increase the harmonisation of rules for better access and security of supply for patients in all EU Member States... Full

New Pricing Agreements And Greater Transparency: What A US MFN Policy Could Mean For France

(6/4, Francesca Bruce, Pink Sheet) ...Pharmaceutical companies in France could see more risk-sharing agreements and the threat of greater drug price transparency if they try to offset the financial impact of a US most favored nations (MFN) policy with higher medicine prices, said Alexandre Regniault, vice president of the industry association, France Biotech... Global Sub. Full

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