Friday, March 13, 2026

 

 

Trump Is Counting on His 'Favorite Mormon' to Deliver Health Care Wins

(3/13, Dan Diamond, The Washington Post) ...[Chris] Klomp, a political unknown before Trump officials tapped him last year to lead the nation's Medicare program, was promoted last month to chief counselor of the Department of Health and Human Services, giving him control of the $2.6 trillion agency's sweeping operations. Every HHS division — with such disparate missions as overseeing drug approvals, approving vaccine initiatives and assessing public health risks — now answers to Klomp, 45... Sub. Req’d

 

Poll: Public Worries About Prescription Drug Costs Reach New High; Most Across Political Parties Want Government to Do More to Regulate Prices

(3/13, KFF) ...The new poll finds 59% of the public now say they are at least somewhat worried about being able to afford prescription drugs for themselves and their families, the largest share since KFF first polled on this question in 2018. This includes about one in five (22%) who are "very worried" about affording prescription drug costs... Full

 

Congressional Democrats Say Trump Tariffs Will Cost US Households More Than $2,500 This Year

(3/13, Paul Wiseman, Associated Press) ...[C]ongressional Democrats warn in a study out Friday, the administration's import taxes will cost American households an average of $2,512 in 2026, up 44% from $1,745 in tariff costs last year...Calling the study "phony," White House spokesman Kush Desai said "President Trump will continue using tariffs to renegotiate broken trade deals, lower drug prices, and secure trillions in investments for the American people."... Full

 

New FDA Guidance Could Elevate Pharma's Biosimilar Market

(3/12, Michael Gibney, Pharma Voice) ...While some biosimilar examples fulfill the promise of lower costs for patients, the margins for companies that make them have become too thin. At the rate of $100 million to $300 million in upfront investment and years of clinical development, "fewer manufacturers will be able — or willing — to bring new biosimilars to market. This means the U.S. market could face diminished competition and higher long-term costs for patients," according to the Biosimilars Council... Full

 

Will New FDA Rules Lead to Biosimilars (Finally) Taking Off in the US?

(3/13, Patrick Burton, Pharma Boardroom) ...Speaking exclusively to PharmaBoardroom, the FDA's biosimilars lead Sarah Yim explains that, significantly, the regulator is reducing the need for large comparative efficacy studies which she suggests "provide minimal information." AAM's Murphy adds that these studies are "blunt tools" that add high cost and time but little scientific value. He suggests that removing them could reduce development costs by tens of millions of dollars per product and shorten market entry timelines by more than a year. Yim also notes that her organisation is also pushing for legislative changes to erase the aforementioned distinction between "biosimilar" and "interchangeable."... Full

 

FDA's First PSG Batch Of 2026 Includes 98 Guidances

(3/12, Urte Fultinaviciute, Generics Bulletin) ...Among the revised PSGs, the FDA highlighted recommendations for four modified-release drug products to remove in vitro alcohol dose dumping studies based on new GDUFA-funded research that a therapeutic equivalence assessment can be made without these studies... Global Sub. Req’d

 

Don't Just Say "We'll Fix It": FDA Wants Real Investigations in Your 483 Response

(3/13, Kalie E. Richardson, Charles D. Snow, Anne K. Walsh, FDA Law Blog) ...While the Draft Guidance may not provide absolute certainty around how to respond to an FDA 483, it does stress the importance of submitting a robust response... Full

 

'Cutting Copays Act' to Eliminate Co-Pays for Medicare Part D Recipients in Kentucky

(3/12, Addie Meiners, WLKY) ...The "Cutting Copays Act" aims to eliminate co-pays for generic prescription drugs for Medicare Part D recipients. [Kentucky Congressman Morgan] McGarvey has tried to get it passed for over a year, but was finally able to get bipartisan support by tucking it into an appropriations bill... Full

 

Rep. Bollin Leads Effort to Protect Medicaid, Lower Prescription Drug Costs

(3/12, Michigan House Republicans) ...House Bill 4839, currently under consideration by the House Appropriations Committee, would require Michigan's Medicaid program to favor generic and biosimilar drugs over more expensive brand-name medications when medically appropriate. Most private insurance plans already operate under similar policies, but Michigan's Medicaid program does not currently include a clear preference for generics... Full

 

 

Hikma Debuts Nucynta ER Rival In US

(3/12, Dave Wallace, Generics Bulletin) ...No generic versions of Nucynta ER are currently shown as approved in the US Food and Drug Administration's drug database, although both Hikma and Humanwell have generic versions of the immediate-release Nucynta listed. Teva has a settlement with Grünenthal – which licenses Nucynta and Nucynta ER rights to Collegium – allowing the Israeli firm to launch a Nucynta ER generic from the start of July 2027, subject to FDA approval, or earlier under certain circumstances... Global Sub. Full

 

Biocon Arm Biocon Pharma Secures US FDA Nod for Generic Liraglutide Injection gVictoza

(3/12, Jomy Jos Pullokaran, CNBC-TV18) ...Biotechnology major Biocon Ltd on Thursday (March 12) said its wholly owned subsidiary, Biocon Pharma Ltd, has received approval from the US Food and Drug Administration (US FDA) for its Abbreviated New Drug Application (ANDA) for Liraglutide Injection (gVictoza), 18 mg/3 mL (6 mg/mL), in single-patient-use prefilled pens... Full

 

Novo, Mylan Seek Judgment on Key Wegovy Patent Before Trial

(3/12, Christopher Yasiejko, Bloomberg Law) ...Novo Nordisk A/S and Viatris Inc.'s Mylan unit asked a Delaware federal court to formalize Mylan's concession that its generic Wegovy injection infringes Novo's compound patent, an agreement that would block the copy until at least December 2031. The proposed judgment would resolve allegations over US Patent No. 8,129,343, which covers the semaglutide compound in Novo's weight-loss drug. That would narrow the case to three later-expiring patents covering formulations of Wegovy's active ingredient and dosing methods... Sub. Req'd

 

Celltrion to Accelerate Biosimilar Pipeline on Eased US Regulations

(3/13, The Korea Herald) ...Celltrion said Friday it will immediately apply newly eased US biosimilar development rules to its pipeline, a move expected to cut development costs and shorten timelines...Celltrion said the change could reduce overall clinical development costs by up to 25 percent, particularly in areas such as immuno-oncology, where reference drugs are expensive... Full

 

 

Lundbeck Eyes US, China Investment as Drug Rewards Lag in Europe

(3/13, Ashleigh Furlong, Bloomberg) ...H. Lundbeck A/S will focus its capital investments on the US and China rather than Europe as the region faces growing pressure to incentivize innovation, according to the Danish drugmaker's chief executive officer. "We see really strong recognition of innovation in the US. That's why it's so attractive," Charl van Zyl said in an interview, adding China is also advancing in technology and AI-driven discovery. "What we don't see is the same in Europe."... Sub. Req'd

 

GSK RSV Vaccine Secures Age Indication Expansion from US FDA

(3/13, Alliance News) ...The London-based pharmaceutical firm said the vaccine has been approved for use in adults aged 18 to 49, who are at increased risk for lower respiratory tract disease caused by RSV... Full

 

Stryker Shipping Still Down in Attack Claimed by Pro-Iran Group

(3/12, Jake Bleiberg and John Tozzi, Bloomberg) ...A cyberattack on Stryker Corp. has kept the medical technology company's ordering and shipping systems offline as the firm continues to struggle to address a crippling hack claimed by a group linked to Iran. Stryker, which makes an array of surgical equipment and medical devices, said in a statement early Thursday that it can view orders placed before the breach. Those orders will be sent out "as soon as our system communications are restored" and staff are working to get them "back up and running as quickly as possible," according to the Michigan-based firm... Sub. Req'd

 

Warning About New Synthetic Opioid Said to Be 10x Stronger Than Fentanyl, Detected in California

(3/12, Jocelyn Fiset, KTLA) ...Several states, including California, have detected cychlorphine mixed with illegal street drugs. It has reportedly also been detected in New York, Pennsylvania, Tennessee, Illinois, Louisiana, Texas, Washington and Nevada. The potent opioid has been linked to multiple overdose deaths, including 19 in Tennessee... Full

 

 

Pharma Exports to the GCC Countries & WANA Region Affected Badly by US-Israel-Iran Conflict: Experts

(3/13, Shardul Nautiyal, Pharmabiz.com) ..."The conflict will exacerbate inflation and downward pressure on growth in energy-import-dependent economies like India, affecting equity markets and industrial activity. Pharma hubs like Bengaluru, a major export centre, could see amplified effects from these global disruptions. If Israeli pharma giants like Teva face supply interruptions, Indian firms might capture more market share in the US and Europe. Overall, while short-term disruptions are acute, the industry may adapt through alternative routes or suppliers, but prolonged conflict could deepen the economic strain," Experts explain... Full

 

India's Boundless Biotech Potential

(3/13, Parag Saxena, The Wall Street Journal) ...India holds a second structural advantage: the world's largest concentration of software engineers. Its digital-payment infrastructure now processes more than 20 billion transactions a month through the Unified Payments Interface. Applying that engineering strength to biology could allow India to leapfrog from manufacturing generics to discovering cures... Sub. Req’d

 

Canada's Pharmaceutical Sovereignty Starts With Generics and Biosimilars

(3/12, Jim Keon, National Newswatch) ...Pharmaceutical sovereignty does not mean producing every medicine domestically. In a highly globalized industry, this is not realistic. But it does mean ensuring Canada has strong domestic manufacturing capacity, combined with resilient international supply chains, so Canadians are not left at the back of the line when disruptions occur... Full

 

French Industry Aims To Improve Medicines Policy Through National Debate

(3/12, Francesca Bruce, Pink Sheet) ...According to [Leem's president, Thierry Hulot], the debate around medicines is too often reduced to budgetary concerns. However, through the consultation, Leem aims to widen the debate to facilitate new proposals that will remove obstacles to innovation and identify priorities for a French health care system under strain... Sub. Req'd

 

Korea to Cut Generic Drug Prices, Offer Incentives to R&D-Focused Pharma Firms

(3/13, Park Ji-su, Seoul Economic Daily) ...According to the pharmaceutical and bio industry on the 13th, the Ministry of Health and Welfare decided at a Health Insurance Policy Deliberation Committee subcommittee meeting on the 11th to differentiate between innovative and general pharmaceutical companies when cutting prices of already-listed generic drugs. A plan to apply lower reduction rates to companies certified as innovative pharmaceutical enterprises and equivalent firms, compared to general companies, is being strongly considered... Full

 

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