Tuesday, October 20, 2026

 

 

Merck Cuts IVF Drug Prices in U.S. Under Trump Tariff Deal

(10/20, Anabelle Colaco, Sydney Sun) ...Under the agreement, Merck's U.S. unit EMD Serono will sell fertility treatments such as Gonal-f, Ovidrel, and Cetrotide directly to consumers at discounts of up to 84 percent off list prices when all three drugs are used together in an IVF cycle...As part of the deal, Merck reached an agreement with the U.S. Commerce Department to exempt its fertility drugs from future industry-specific tariffs, provided it increased investment in American manufacturing and research... Full

 

Drugmakers Seek to Intervene in Lawsuit Challenging 340B Pilot

(10/19, Jill Hughes, Healthcare Dive) ...On Oct. 14, pharmaceutical companies AbbVie, Bristol-Myers Squibb and Boehringer Ingelheim filed a motion to intervene in the American Hospital Association's lawsuit against the HHS. Hospitals had challenged the Trump administration's new 340B pilot, which would trade upfront discounts for post-purchase rebates for drugs, earlier this month... Full

 

A $100 Billion Drug Discount Program Is Finally Facing New Scrutiny

(10/19, Sally Pipes, Forbes) ...HRSA should preserve the rebate pilot and use what it learns to strengthen oversight. After more than three decades of expansion, 340B needs more than assurances that its benefits reach the intended patients. It needs proof... Full

 

The Pill in Your Medicine Cabinet Is a National Security Issue

(10/19, Rep. Bob Onder (R-Mo.), The Hill) ...In July, batches of cetirizine, the generic version of Zyrtec, were recalled after being contaminated with another drug during manufacturing in India. The contamination was not caught at the factory. It was not caught by FDA import screening. It was caught because a pharmacy technician happened to notice something looked wrong. It is alarming that systems currently in place were not adequate to ensure drug purity and safety... Full

 

QMSR: FDA, Industry Experts Discuss Transition, Inspection Anxiety

(10/19, Ferdous Al-Faruque, Regulatory Focus) ...Doug Reimer, a senior director of regulatory compliance at Johnson & Johnson, said the switch to QMSR was not as traumatic as the medtech industry initially feared. On the contrary, he said that it has learned a lot about the new regulation over the past eight months and is happy about how it has been implemented... Full

 

 

Johnson & Johnson's Tremfya Shows Fistula Remission at 48 Weeks in Crohn's

(10/19, StreetInsider.com) ...Johnson & Johnson (NYSE: JNJ) announced one-year results from its Phase 3 FUZION study showing that Tremfya (guselkumab) maintained or improved fistula remission through 48 weeks in adults with Crohn's disease with perianal fistula. The findings were presented at the 2026 United European Gastroenterology Week... Sub. Req'd

 

Eli Lilly's Omvoh Takes Phase 3 Win in Pediatric UC, Fueling Expansion Ambitions

(10/19, Donavyn Coffey, Fierce Pharma) ...The Indianapolis-based drugmaker just announced a positive readout for its Shine-2 phase 3 trial of Omvoh in pediatric patients ages six to 17 years with moderately to severely active ulcerative colitis (UC). Half of the children enrolled in the single-arm study achieved clinical remission by one year, achieving the primary endpoint in what Lilly hailed as the longest pediatric IL-23p19 study to date... Full

 

Pfizer Makes 'Business Decision' to End Phase 2 Trial of Autoimmune Drug as Program's Future Uncertain

(10/20, James Waldron, Fierce Biotech) ...The Big Pharma had been evaluating the therapy, dubbed PF-06835375, in a phase 2 study of 61 patients with primary immune thrombocytopenia (ITP) that kicked off in 2022, according to the federal trials register. However, Pfizer confirmed to Fierce on Monday that this study had been terminated "due to a business decision."..."The decision to terminate the trial was not based on any safety concerns," a spokesperson pointed out... Full

 

 

Alvotech Receives FDA Approval for New SIMLANDI® Manufacturing Process That More Than Doubles Output Per Batch

(10/20, Alvotech) ...The FDA approval allows Alvotech to introduce Process 2.0 for the manufacture of adalimumab drug substance in its DSM2 manufacturing suite in Reykjavik, Iceland. The new process more than doubles drug substance output per batch without changing the upstream manufacturing scale... Full

 

Samsung Bioepis Secures 10-Year Biosimilar Supply Deal in Brazil

(10/20, Lim Ye-jin, The Korea Herald) ...Samsung Bioepis said Tuesday it has secured a 10-year deal to exclusively supply its rare disease biosimilar SB12 to Brazil's public health system, strengthening its foothold in Latin America's largest pharmaceutical market... Full

 

EMA Endorsements Add Further Biosimilar Competition On Lucentis And Neulasta

(10/19, Dave Wallace, Generics Bulletin) ...The latest meeting of the European Medicines Agency's Committee for Medicinal Products for Human Use has delivered endorsements for two biosimilars: Accord's Fovlussea (ranibizumab) rival to Lucentis and the Neuzafy (filgrastim) version of Neupogen from Aurobindo's CuraTeQ... Global Sub. Full

 

Celltrion's Remsima Overtakes Original Drug in Japan, Claiming No. 1 Spot With 48% Market Share

(10/20, Choi Mun-hee, BusinessKorea) ...Celltrion announced on Oct. 20 that Remsima (infliximab), its autoimmune disease treatment, captured a 48% share of Japan's infliximab market in July, becoming the most prescribed product in its category. The achievement is particularly notable in Japan, a traditionally conservative pharmaceutical market known for its high barriers to entry... Full

 

Natco Pharma Launches Generic Cancer Drug Carboplatin in US

(10/19, PTI) ...The product, a generic version of Paraplatin, has been launched in manufacturing collaboration with Chennai-based Teyro Labs Pvt Ltd, the company said in a regulatory filing. The launch helps address a critical shortage of the product in the US market, Natco Pharma stated... Full

 

Biosimilar Manufacturers Bet on Golden Years to Come

(10/19, Daria Sukharchuk, Rapporteur) ...Both Sandoz and Formycon are concentrating their efforts on oncology and immunology, with a focus on monoclonal antibodies, laboratory-made proteins designed to recognise and bind to specific targets in the body. For Sandoz, these therapeutic areas will "remain core", with about 80% of its future biosimilar pipeline focused on them, according to Rebecca Guntern, the company's chief commercial officer... Full

 

Ustekinumab Biosimilar Switch Holds Up in Crohn Disease

(10/19, Skylar Jeremias, The Center for Biosimilars) ...Across 18 centers and 462 patients, clinical success held steady whether patients switched or continued on the originator, adding some of the most convincing real-world evidence yet that a procurement-driven, nonmedical switch does not erode disease control... Full

 

 

Merck KGaA Buys Silence in $1.3B Deal After siRNA Drug's Phase 2 Blood Cancer Win

(10/19, James Waldron, Fierce Biotech) ...Germany's Merck KGaA has picked up Silence Therapeutics to the tune of $1.3 billion in the wake of the British biotech's mid-stage success for its challenger to Takeda's Mimrylo. The all-cash deal will see Darmstadt-based Merck pay $20 per American depositary share, with each ADS representing three ordinary shares of Silence... Full

 

Antheia Gets $80M Conditional DOD Loan to Onshore to the US

(10/19, Anna Brown, Endpoints News) ..."Over time, we aim to manufacture Antheia's full pipeline of key starting materials and active pharmaceutical ingredients in the US," CEO and co-founder Christina Smolke told Endpoints News in an email. Antheia further believes, with continued investment, the US could become a key exporter of raw materials in as little as two years, Smolke said... Sub. Req'd

 

After Migraine Rebrand, TriGemX is Going Public via SPAC Deal

(10/19, Elizabeth S. Eaton, FirstWord PHARMA) ...The biotech announced Monday that it will list on NASDAQ by merging with a SPAC formed by investment firm TCGX. Gross proceeds are expected to reach about $246 million, comprising $86 million in the SPAC's account and a $160-million PIPE from backers including Viking Global Investors, ADAR1 Capital Management, BVF Partners, Samsara BioCapital and Vianti Capital... Full

 

Roche Pauses Future Germany Investments, Joining Growing Chorus of Pharma Pullbacks

(10/19, Angus Liu, Fierce Pharma) ...Speaking with the German newspaper Die Welt, Daniel Steiners, head of Roche Germany, said that the company has "put all future investment decisions in Germany on hold for the time being," according to Reuters. Roche paused future investments in Germany this summer, a Roche spokesperson told Fierce, pointing to a report in August by the Financial Times. Steiners blamed the country's recent healthcare reform plan that intends to cut drug prices further, asserting that the move has "recently destroyed a lot of trust."... Full

 

Exclusive: Drug Deals Shift Toward Milestones

(10/20, Katherine Davis, Axios) ...Big drugmakers are shifting more licensing-deal value to future milestones, with upfront cash representing a smaller share, per a JPMorgan-DealForma report reviewed exclusively by Axios Pro... Full

 

Launch Prices for New Medicines Dipped Slightly Last Year but Remain High, Analysis Finds

(10/20, Ed Silverman, STAT+) ...About one in four drugs launched in 2025 had an annual net price exceeding $500,000, while another 34% were priced between $200,000 and $500,000, according to the analysis by the Institute for Clinical and Economic Review, a nonprofit that assesses the value of medicines, and West Health, a nonprofit that advocates for lower health care costs... Sub. Req'd

 

Alternative PBM Satisfaction Declined in 2026, Shrinking the Advantage Over the Big Three PBMs

(10/20, Bryce Platt, PharmD, Drug Channels) ...Below we examine the shrinking satisfaction advantage, the choices plan sponsors are considering for 2027, and why the grass may not always be greener on the alternative PBM side... Full

 

 

Medicines For Europe Urges EU States To Follow Dutch Example On Implementing UWWTD

(10/19, Anabel Costa-Ferreira, Generics Bulletin) ...The European generics and biosimilars trade body, Medicines for Europe is urging governments to follow in the footsteps of the Netherlands, which has proposed the implementation of the controversial Urban Wastewater Treatment Directive without transposing Article 9 and Annex III, at this stage... Global Sub. Full

 

France's New Drug Pricing Policy 'Not a Response' to US Pressure

(10/20, Yuqing Yang, Rapporteur) ...European countries are under growing pressure from US President Donald Trump's 'Most-Favoured-Nation' policy, which seeks to link US prices for certain medicines to the lowest prices paid in other developed countries. The policy has fuelled fears that pharmaceutical companies could delay or forgo launches in Europe, or push for higher prices, to protect their returns in the US... Full

 

Sweden and Denmark See No MFN Hit to Drug Launches, Concerns Remain

(10/20, Rapporteur) ...With 59 filed between January and September, this year is already on course to overtake the 74 recorded across the whole of 2025. "We cannot see any real difference in our figures either way; perhaps slightly more than at the same time last year," Johan Pontén, senior advisor on international affairs at Swedish pricing agency TLV, told Rapporteur... Full

 

Tariff Risks Reshape Indian Pharma's Global Playbook

(10/19, Manu Kaushik, Financial Express) ...Still, the Indian industry is resilient and combative. "We have over a decade of experience in effervescent technology and a presence in around 30 countries. The US remains an important market for our planned expansion. Tariff uncertainty has prompted us to reassess the timing, but we intend to hold on to the decision and evaluate how best to move forward as the policy environment becomes clearer," said the mid-sized company's co-founder... Full

 

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