Friday, November 6, 2026

 

 

Bayer Weighs Drug Price Deal With Trump Administration as Tariff Risks Loom

(11/6, Kimberly Redmond, NJ Biz) ...During [Bayer's] Nov. 3 third quarter earnings call, Bayer Chief Financial Officer Judith Hartmann said executives continue to evaluate what the Trump administration's Most Favored Nation policies could mean for its pricing and launch strategies. Hartmann added that Bayer already factored U.S. tariffs on patented pharmaceuticals into guidance for this year... Full

 

MFN Revisions, Codification Unlikely In Divided US Government, Pfizer's Bourla Suggests

(11/5, Cathy Kelly, Pink Sheet) ...Pfizer Chairman and CEO Albert Bourla does not expect the newly-elected and Democratic-controlled Congress to revise the Most Favored Nation drug pricing agreements reached between 26 manufacturers and the Trump Administration. Bourla said during Pfizer's Nov. 3 earnings call that "I think that in any case, it looks like we will have a split government."..."So I don't think that many things can move legislation-wise" and "I don't expect any changes in MFN," he said... Global Sub. Full

 

Trump's Drug Negotiation Rule Kicks Off New Fight for Pharma

(11/5, Nyah Phengsitthy, Bloomberg Law) ...The Trump administration rolled out Thursday the final blueprint for how it will run the fourth cycle of Medicare drug price negotiations, finalizing a new provision that opens the door to fresh legal challenges from pharmaceutical companies. The final rule grants the Centers for Medicare & Medicaid Services the power to slash the prices of negotiation-eligible drugs along with their newer formulation versions, if the agency determines there's no clinically meaningful difference between the products... Sub. Req'd

 

Democrats' Victory Tees Up Focus on Trump's Big Pharma Deals

(11/6, Nyah Phengsitthy and Victoria Knight, Bloomberg) ...The administration's efforts to enshrine the most-favored-nation policy into law could also start up again, but it remains unclear how aggressively Trump is willing to advocate for it. "It's possible that many Democrats would be interested in working with him," said Rachel Sachs, a former senior adviser in the Department of Health and Human Services Office of the General Counsel, now a professor at Washington University in St. Louis School of Law. "However, this is no guarantee that he'd actually sign such a bill."... Sub. Req'd

 

How Democrats Will Use Their Health Oversight Powers

(11/6, Adriel Bettelheim, Axios) ...What we're hearing: The House Oversight, Energy and Commerce and Ways and Means committees will be focal points of early activity, along with the Senate health and Finance committees... Full

 

ASPR Builds On Drug Reshoring Project With New DOD, Commerce Partnership

(11/5, Lauren Brensel, Inside Health Policy) ...The Administration for Strategic Preparedness and Response (ASPR) will work with the Department of Defense and the Department of Commerce to assess the pharmaceutical key starting materials (KSM) industrial base to strengthen the U.S. drug supply, HHS said Tuesday (Nov. 3) -- the latest initiative that's part of a broader effort within the Trump administration to reshore domestic drug development... Sub. Req'd

 

Pharma's Trade Group Spent Heavily on Search Ads to Sway Public Opinion

(11/5, Ed Silverman, STAT) ...[PhRMA] spent roughly $32 million on ads linked to insurance and health plan searches, while $28 million was spent directing people to its web pages and domains criticizing pharmacy benefit managers, which drugmakers argue are the true culprits behind the rising prices for many medicines... Sub. Req'd

 

FDA Official Expects User Fee Reauthorization Despite Midterm Shakeup

(11/5, Joanne S. Eglovitch, Regulatory Focus) ...Lowell Zeta, the acting chief of staff for Office of the Commissioner at FDA, made these remarks during a fireside chat at the Association for Accessible Medicines' (AAM) GRx+Biosim conference on Wednesday. Zeta discussed the recent election and FDA's policy priorities with Maryll Toufanian, senior vice president of regulatory strategy and government affairs at Amneal Pharmaceuticals... Full

 

US FDA Creates Cross-Product Supply Chain Council In New Office Of National Health Security

(11/5, Maaisha Osman, Pink Sheet) ...The US [FDA] has created an internal group to address supply chain issues across product areas, Brooke Courtney, senior regulatory counsel in the Office of the Commissioner, said Nov. 3 during the Association for Accessible Medicines' GRx+Biosims conference that many supply chain issues cut across product areas. The coordination role is meant to give different offices and programs the same situational awareness... Global Sub. Full

 

FDA's Elsa AI Tool Use On The Rise, As Generics Industry Seeks Safeguards

(11/6, Anabel Costa-Ferreira, Generics Bulletin) ...To be useful, AI must be "validated, traceable and accountable": these were the words of Nimi Chhina, vice president of regulatory affairs policy & intelligence, digital, compliance & operations at Teva, whose sentiment was shared by fellow panelists throughout the discussion... Global Sub. Full

 

CMS Finalizes Combo Drug Policy As Botox Ruling Clouds Negotiation Authority

(11/5, Maaisha Osman, Pink Sheet) ...CMS finalized its general fixed combination policy and a narrower policy for products that are new formulations of existing drugs with technical modifications for clarity. Under the narrower policy, if an added ingredient creates a new formulation and enables an alternative route of administration for the co-administered ingredient, CMS will group all dosage forms and strengths of the shared ingredient from the same NDA or BLA holder when identifying a qualifying single source drug... Global Sub. Full

 

New Rule Will Bring Down Drug Costs by Forcing Competition, Ohio Expert Says

(11/6, Marty Schladen, Ohio Capital Journal) ...The Columbus-based expert, Antonio Ciaccia, has advocated for years to force more transparency on the middlemen, known as pharmacy benefit managers or PBMs. As state legislatures and health agencies have passed laws aimed at shedding light on the practices of the big PBMs, which are part of huge health conglomerates, PBMs simply changed tactics, Ciaccia said. "This ends the game of whack-a-mole," he said during a panel discussion that was part of the announcement at the Labor Department in Washington, DC... Full

 

 

Neurocrine Biosciences Presents New Tardive Dyskinesia Survey Results Showing Fewer Work and School Disruptions with INGREZZA® (valbenazine) Capsules

(11/6, Neurocrine Biosciences) ...Neurocrine Biosciences, Inc. today announced the release of findings from a new survey showing that adults with tardive dyskinesia (TD) reported fewer disruptions to work and school after starting treatment with INGREZZA® (valbenazine) capsules.1 A separate post-hoc analysis of the KINECT-PRO™ Phase 4 open-label study showed robust patient-reported improvement with INGREZZA across all six physical and socio-emotional areas measured by the Tardive Dyskinesia Impact Scale (TDIS™) among participants who reported impacts in those areas at baseline... Full

 

Sanofi Moves Ahead with Phase 3 Clinical Trials for Dupixent SC Formulation Using Alteogen's 'ALT-B4'

(11/6, Ji, Yong Jun, The Bio) ...The Phase 3 trial plans to enroll approximately 150 adolescents and adults aged 12 and older with moderate to severe atopic dermatitis. It will directly compare dupilumab co-formulated with Alteogen's 'ALT-B4' against the existing approved dupilumab formulation, both administered subcutaneously (SC)... Full

 

Alkermes Showcases Research From Psychiatry and Sleep Portfolios at the Neuroscience Education Institute Fall Congress

(11/6, Alkermes plc) ...The company will present data related to LYBALVI® (olanzapine and samidorphan), ARISTADA® (aripiprazole lauroxil) and LUMRYZ® (sodium oxybate) extended-release oral suspension, as well as alixorexton, the company's novel, investigational, oral, selective orexin 2 receptor (OX2R) agonist in development for the treatment of narcolepsy type 1 (NT1), narcolepsy type 2 (NT2) and idiopathic hypersomnia (IH)... Full

 

 

Fresenius Sees Biosimilars Industry At An 'Inflection Point' As It Targets Top-Three Position

(11/6, Dave Wallace, Generics Bulletin) ...Fresenius said it was building a "vertically-integrated bio powerhouse" through two key recent transactions: a deal struck a month ago that is worth up to €750m to buy out the remaining 45% of biosimilars developer mAbxience; and a 37-product alliance with WuXi Biologics that was announced just this week... Global Sub. Full

 

Bio-Thera Announces NMPA Approval of BAT2506, the First Golimumab Biosimilar Approved in China

(11/6, Bio-Thera Solutions) ...Bio-Thera Solutions, Ltd., a commercial-stage biopharmaceutical company developing innovative therapies and biosimilars, today announced that the National Medical Products Administration (NMPA) has approved its marketing authorization for BAT2506, a golimumab biosimilar. This approval marks the first golimumab biosimilar approved in China... Full

 

Amneal Dreams To Be The Second Xolair Rival In The US, Projecting Launch In Late 2027

(11/5, Urte Fultinaviciute, Generics Bulletin) ...During the Q3 2026 earnings call, co-CEO Chirag Patel said Amneal has a goal date early next year for the biosimilar, which was filed "earlier than expected" with the US [FDA] last September. Without giving much detail, Patel said there was a patent settlement with Xolair originators but refused to comment on it or market entry. However, he disclosed that Amneal's omalizumab candidate is expected to be the second Xolair biosimilar on the US market in late H2 2027... Global Sub. Full

 

Dr Reddy's Brazilian Semaglutide Nod Sets Up A Competitive Generic GLP-1 Market

(11/5, Dave Wallace, Generics Bulletin) ...MV Ramana, the company's CEO for global generics, said "our focus with semaglutide is to expand access to this treatment option across markets where the patient need is significant. Brazil, with its substantial burden of diabetes, is an important part of that journey."... Global Sub. Full

 

Alembic Eyes US Exclusivity For Venetoclax After FDA Approval

(11/5, Anabel Costa-Ferreira, Generics Bulletin) ...Alembic has received final approval from the US [FDA] for an abbreviated new drug application for venetoclax tablets across three strengths, with Alembic also claiming potential eligibility for 180 days of generic drug exclusivity... Global Sub. Full

 

 

Cigna Boosts 2026 Outlook as Insurance, Specialty Pharmacy Profits Climb

(11/5, Rebecca Pifer Parduhn, Healthcare Dive) ...Earnings in Cigna's specialty segment - one of its fastest-growing businesses - were up 15% year over year, despite revenue only increasing 1%, thanks to stronger adoption of cheaper biosimilar and specialty generic drugs... Full

 

Celltrion Nears Annual Target on Biosimilar Surge

(11/6, Lee Tae-hee, Korea JoongAng Daily) ...Strong sales of its biosimilars launched last year - Steqeyma, Omlyclo, Eydenzelt, Stoboclo, Osenvelt, and Avtozma - helped the earnings growth. Revenue generated from the products totaled 388 billion won in the third quarter, up 335 percent on year. The figure rose 23.4 percent compared to the previous quarter... Full

 

ANI Makes $560m Play for Egetis and its Approved Orphan Drug Emcitate

(11/5, Donavyn Coffey, Fierce Pharma) ...Alongside its Q3 earnings Thursday, the New Jersey-based pharma announced a $560 million offer for Swedish rare disease drugmaker Egetis Therapeutics. Should the deal go through, Egetis would bring its recently approved medicine Emcitate into the ANI fold... Full

 

India's Gland Pharma Beats Quarterly Estimates on Strong Europe, US Sales

(11/6, Kashish Tandon, Reuters) ...Gland Pharma reported a bigger-than-expected 58.3% jump in second-quarter profit on Friday, boosted by strong sales in its key European and US markets... Full

 

India's Glenmark Quarterly Profit Falls on Lower North America Sales

(11/5, Reuters) ...Glenmark Pharmaceuticals posted a 56.8% drop in second-quarter profit on Thursday, weighed down by lower revenue from its North American business. The company reported a consolidated net profit of 2.64 billion rupees ($27.93 million) for the quarter ended September 30, compared with 6.10 billion rupees a year ago... Full

 

Pfizer Plans $650M Manufacturing Center at Groton Campus to Expand Clinical Research

(11/6, Michael Puffer, Hartford Business) ...The facility will produce active pharmaceutical ingredients and drug products used in Pfizer-sponsored clinical trials, according to an announcement from AdvanceCT, the state's nonprofit economic development organization. Construction is expected to begin in the second quarter of 2027, with operations scheduled to begin in mid-2031... Full

 

Disintegration: Adam's Four Takeaways from the CVS Health Breakup

(11/5, Adam J. Fein, Ph.D., Drug Channels) ...This split is a belated acknowledgement that the synergies between CVS Pharmacy and Caremark were overblown from the start. As I argue below, CVS Pharmacy will have greater freedom to make the hard choices—and also find new friends. Regulatory and legislative risks are real, but I view this primarily as a strategic and financial decision... Full

 

 

Bulgaria's Spending on Generic Medicines Drastically Below EU Average

(11/5, Krassen Nikolov, Rapporteur) ...The industry sees this as a missed chance to contain rising healthcare costs and widen patients' access to treatment without out-of-pocket payments. "There is room for improvement when it comes to investment in generic medicines," Nikolay Hadzhidontchev, chief executive of Teva Bulgaria and chairman of BGPharmA, told a conference in Sofia. He said the share of generic and biosimilar medicines in public pharmaceutical spending should rise significantly in the coming years... Full

 

Europe Has the Science. Can Patients Access It?

(11/6, The Parliament Magazine) ...Europe has built world-class research networks, specialist centres and data infrastructures, but too many patients remain disconnected from the clinical trials that could change their lives. MEP Vytenis Andriukaitis and Pfizer's Donna Boyce discuss how to change this... Full

 

Patients Continue Missing out in UK Industry Clinical Trial Recruitment

(11/5, The Pharma Letter) ...The ABPI's latest annual clinical trials report published today shows that just 17,618 people took part in industry clinical trials in the NHS in 2025/26, down from 19,507 the year before. This is 31% fewer than in 2022/23. Only 3.8% of interventional clinical trial participants were recruited to industry sponsored studies, a proportion which was consistently higher than 10 per cent pre-pandemic... Sub. Req'd

 

Industry Fears Making EU Sandboxes 'Too Exceptional' Will Backfire On Innovation

(11/5, Dean Rudge, Pink Sheet) ..."Eligibility conditions for entry to a regulatory sandbox should be based not only on where the legislation blocks development, but situations where an existing regulatory pathway proves to be so challenging that developers do not pursue development of that innovation." That is the message to the Pink Sheet from the European research-based industry federation, EFPIA, on regulatory sandboxes, which are being introduced under the forthcoming EU pharmaceutical reform package... Global Sub. Full

 

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