Monday, November 2, 2026

 

 

What's Next? Five Things To Look Out For In November

(11/1, Dave Wallace, Generics Bulletin) ...Teva will host an R&D day on Nov. 11 in New York, where the firm's leadership will "discuss its R&D pipeline, its near-term value-creation potential over the next five years, and Teva's ongoing transformation into an innovative biopharma company."...Teva's increased focus on its R&D activities forms part of the company's ongoing "Pivot to Growth" strategy, which has seen the firm concentrate on higher-margin and more innovative product opportunities – including biosimilars, complex generics and injectables – to drive its business, while still retaining its cash-generative generics interests... Global Sub. Full

 

Teva Israel CEO Yossi Ofek: 'I Don't Make the Decisions. My Team Does'

(10/31, Roy Katz, Ynet News) ...Yossi Ofek, 62, is CEO of Teva Israel and also head of its Africa, Middle East and Ukraine cluster...What's the best business decision you've made as an executive? "Hiring the people I work with at Teva Israel. Every one of them is better than me at something, whether it's understanding consumers or investments. I don't really see my job as traditional management. It's more like coaching a soccer team. It's about leadership, bringing people together and winning as a team... Full

 

H.C. Wainwright Starts Teva Pharma (TEVA) at Buy

(11/2, StreetInsider.com) ...H.C. Wainwright analyst Douglas Tsao...comments "An innovative biopharma emerging from a generics giant's shadow; initiating at Buy, $52 price target. We can understand why some investors have been slow to buy into the company's transformation, but we think there is more than enough evidence now to buy into the transformation that has been led by Richard Francis since taking over the role of CEO in 2023... Sub. Req'd

 

 

Dems Prep For Major Probe Of TrumpRx, MFN Deals If They Win Midterms

(10/30, Lauren Brensel, Inside Health Policy) ...Days ahead of the midterm elections, House Energy & Commerce Committee ranking Democrat Frank Pallone (NJ) is pushing the Government Accountability Office to investigate the White House's TrumpRx deals with pharmaceutical companies and whether the deals are really benefitting consumers. It's the second such request from a prominent Democrat, signaling an investigation of TrumpRx would be a key part of Democrats' drug pricing agenda if the party takes control of Congress... Sub. Req'd

 

New Mandates Force PBMs to Disclose Business Dealings

(10/30, Adriel Betthelheim, Axios) ..."This is a win for every American worker who has ever paid too much at the pharmacy counter," said Labor Secretary Keith Sonderling. "For years, PBMs have operated in the shadows, pocketing hidden fees while workers and employers were left in the dark."... Full

 

The Trust-Busters Going After CVS Are Republicans

(11/1, Kelly Hooper, Politico) ...A number of red states, as well as some blue ones, are poised to crack down on pharmacy conglomerates, following Tennessee and Arkansas, where GOP governors Bill Lee and Sarah Huckabee Sanders signed laws to bar companies from owning both pharmacies and pharmacy benefit managers, which negotiate drug prices on behalf of insurance plans... Full

 

US FDA Strips Boxed Label Warnings From Three Menopause Hormone Patches, Eyes OTC Move

(10/30, Sue Sutter, Pink Sheet) ...The US [FDA] is leveraging product labeling changes and manufacturing supplements, and eyeing potential over-the-counter availability, to expand access and bolster the supply of menopausal hormone therapy products. The agency on Oct. 30 announced the removal of boxed warnings on cardiovascular risk, breast cancer and probable dementia from the labels of three estradiol transdermal patch products - Noven Pharmaceuticals' Minivelle, and Sandoz's Vivelle and Vivelle-Dot... Global Sub. Full

 

Michigan Hospital Loses Bid to Recoup Drug Discounts in US Plan

(10/30, Nyah Phengsitthy, Bloomberg Law) ...The decision deals a setback to the hospital's legal battle alleging the agency unlawfully cut off access to discounts when it rejected the healthcare provider's designation as a disproportionate share hospital (DSH). The critical classification would allow for access to steep drug discounts from manufacturers under the federal 340B Drug Pricing Program... Sub. Req'd

 

AAM Comments on Department of Labor PBM Transparency and Disclosure Rule

(11/2, AAM) ..."While this rule is an important step forward, more work needs to be done to reform opaque PBM practices and promote policies that will put generic and biosimilar medicines first. We are the only sector of the healthcare ecosystem that continues to drive down costs for patients through innovation and competition. When a generic or biosimilar is on the market, it should immediately be made available and prioritized for patients."... Full

 

 

China's InventisBio Delivers Competitive TYK2 Data in Phase 3 Psoriasis Win

(11/2, Nick Paul Taylor, Fierce Biotech) ...InventisBio randomized 391 people in China to receive one of two nomelcitinib regimens or placebo. At Week 16, more than 70% of patients in the two treatment arms had experienced at least a 90% improvement on the Psoriasis Area Severity Index (PASI). InventisBio has yet to share placebo data, but the biotech said nomelcitinib performed "significantly" better than the control, achieving the trial's primary endpoint... Full

 

Two Leading Labs Confirm RHB-204 MAP-Killing Effect for RedHill's Crohn's Disease Candidate

(11/2, RedHill Biopharma Ltd.) ...The two sets of studies led by Professor Tim Bull from City St George's University of London, and Prof Irene Grant, Professor of Microbiology and Food Safety, Queen's University Belfast and Dr Hannah Dane, support the potential for RHB-204's role in MAP-related Crohn's disease (CD) through demonstrated RHB-204 comparability to RedHill's RHB-104, which met the primary endpoint with statistical significance of its positive Phase 3 clinical trial, showing RHB-104 plus standard of care (SoC) to be 64% more effective than SoC alone, in treating CD compared to the placebo (standard of care only) group (p = 0.0048)... Full

 

IXICO Wins £2.7m Huntington's Disease Trial Contract

(11/2, Proactive Investors) ...The six-year agreement, announced on Monday, is with an international biotechnology company and is expected to generate £2.7 million in revenue for the London-listed neuroscience specialist. It is the second phase 3 contract in Huntington's disease awarded to IXICO in the past 12 months, strengthening its position as a partner to biopharmaceutical companies developing treatments for the neurodegenerative condition... Full

 

 

Fresenius Taps China's WuXi to Expand Biosimilar Drug Portfolio

(11/2, Sonja Wind, Bloomberg) ...The German hospital and drugs company agreed on what it called a "pay as you go" structure for the deal on as many as 37 molecules, the company said Monday, adding to the 29 that Fresenius currently has. Unlike generics, which are exact copies of the drug they are based on, biosimilars are imitations of a biological medicine that are often complex and expensive to produce... Sub. Req'd

 

Keytruda Biosims Are Coming — But They Face an Uphill Battle

(10/30, Kelly Bilodeau, PharmaVoice) ...Without unwinding this tangle of deals between drug companies, PBMs, insurance companies, pharmacies and hospitals, there's little chance of a market in which competition reliably translates into lower consumer costs, [Michael Abrams, managing partner at Numerof & Associates,] said. And this complex web that favors branded drugs could prevent Keytruda biosimilars from taking off... Full

 

After A Long Wait, Xbrane Gets FDA Approval For Lucentis Biosimilar

(10/30, Anabel Costa-Ferreira, Generics Bulletin) ...Xbrane Biopharma has announced US [FDA] approval for its Lucentis (ranibizumab-blrz) biosimilar, providing a further cost-effective treatment option for patients with neovascular (wet) age-related macular degeneration (wAMD) and other serious eye conditions... Global Sub. Full

 

Korea Biosimilar Approvals Stall as India and China Gain U.S., EU Wins

(11/1, Hong Da-yeong, ChosunBiz) ...It emerged on the 1st that Korea's biosimilar (biosimilar) corporations did not receive a single product approval in the United States or Europe this year. The Korea Biotechnology Industry Organization said in a recent report, citing Biopharma APAC's tally, that this was the case... Full

 

Alembic Pharmaceuticals Receives USFDA Final Approval for Venetoclax Tablets

(10/31, Indian Pharma Post) ...Alembic Pharmaceuticals Limited has secured final approval from the US [FDA] for its Abbreviated New Drug Application (ANDA) for Venetoclax Tablets in 10 mg, 50 mg, and 100 mg strengths... Full

 

In HelloNation, Prescription Savings Expert Carl Stecker Reviews What Patients Need to Know About Generic vs. Brand Name Drugs

(10/30, HelloNation) ...Are generic medications truly as effective as their brand-name counterparts? A HelloNation article addresses that question directly, clarifying how the FDA approval process for generic drugs works and what patients should understand before making decisions about their prescriptions... Full

 

 

AbbVie Revenue Rises on Strength in Immunology, Neuroscience

(10/31, Kelly Cloonan, The Wall Street Journal) ...In AbbVie's immunology portfolio, revenue climbed 16% to $9.17 billion, driven by arthritis and Crohn's disease treatments like Skyrizi, Rinvoq and Humira. Revenue in the company's neuroscience portfolio gained 19% to $3.39 billion, while its oncology business reported a 0.8% uptick. Aesthetics revenue fell 1.4%... Sub. Req'd

 

Sanofi CEO Says Deals Needed to Navigate Dupixent Patent Cliff

(10/30, Matthew Dennis, FirstWord PHARMA) ...And reiterating previous comments, Chief Financial Officer François-Xavier Roger indicated that Sanofi would look at larger deals than its historical range of $2 billion to $5 billion. He noted that the company is increasingly interested in acquisitions that would give it access to drugs in later stages of development, ?or already on the market, including "assets [that] are more expensive."... Full

 

AstraZeneca Launches $1.5b Cost-Saving Plan to Reinvest in Drug Pipeline

(10/30, Matthew Dennis, FirstWord PHARMA) ...Chief Financial Officer Aradhana Sarin said the programme is "not targeted to like one therapy area or one unit or one specific geography," but is instead looking at opportunities across the company "to align our investments." Speaking on an earnings call, CEO Pascal Soriot explained that the programme has been in the works since the beginning of the year, but has been announced now as "we have to redeploy resources…we have a pipeline we need to support."... Full

 

Regeneron Reaps Surging Dupixent Sales to Crush Expectations

(10/30, Elizabeth S. Eaton, Investor's Business Daily) ...The drugmaker's top line benefited from its collaboration with Sanofi, with whom it jointly develops inflammatory disease drug Dupixent. The French pharma, which also shared its third-quarter results on Friday, records Dupixent's total global net sales; it reported a 35% increase for the quarter to $6.5 billion, ahead of forecasts for $6.2 billion... Sub. Req'd

 

Pharma's Next Cash Cows Could Be Specialized Treatments

(11/2, Adriel Bettelheim, Axios) ...The search for new blockbusters is playing out in a highly charged environment. Drugmakers and biotechs not only have to figure out how to grow outside of crowded categories but also how much payers value new classes of drugs, Evaluate says... Full

 

Pfizer Looks to Reroute Supply after Flooding Sidelined India Injectables Plant

(10/30, Fraiser Kansteiner, Fierce Pharma) ...Pfizer said it is "putting every effort behind restoring product supply," while also "evaluating alternative sites within our global manufacturing network and third-party manufacturing options to help mitigate the impact on supply where possible."... Full

 

 

Sanofi May Seek Higher European Drug Prices, Not Withhold Launches, Under Trump Deal

(10/30, Maggie Fick, Endpoints News) ...The French drugmaker intends to continue launching new medicines across Europe, while potentially seeking higher prices rather than lowering US launch prices, its CFO François-Xavier Roger said on Friday's third-quarter earnings call. The comments put more detail behind a position laid out last week on Trump's "most-favored-nation" policy by new CEO Belén Garijo. She rejected withholding treatments from European patients for purely economic reasons... Sub. Req'd

 

Faster EU Trial Review Will Mean Little If Sponsors Cannot Keep Up, Novartis Says

(10/30, Dean Rudge, Pink Sheet) ...Drug companies hoping to capitalize on faster EU reviews of multinational clinical trial applications will have to accelerate their own clinical trial start-up preparations. That is the message from Novartis's Martin O'Kane based on his company's experience as an early participant in FAST-EU, the pilot testing a 70-day timeline for the assessment of multinational trial applications within the existing Clinical Trials Regulation (CTR)... Global Sub. Full

 

EU Opens Smoother Import Route For Singapore-Made APIs

(10/30, Neena Brizmohun, Pink Sheet) ...The EU has eased regulatory requirements for imports of Singapore-manufactured active pharmaceutical ingredients (APIs) by recognizing the country's good manufacturing practice (GMP) and regulatory framework for such substances as equivalent to its own... Global Sub. Full

 

Pharma Giants Pay Millions to Russian Distributor Entangled in Corruption Allegations to Win Cancer Drug Business

(11/2, Sydney P Freedberg, Delphine Reuter, International Consortium of Investigative Journalists) ...Merck wasn't the only major Western drugmaker to partner with a politically connected Russian distributor entangled in corruption allegations. Nor was it the only one to operate in a system in which improper payments, conflicts of interest, bid rigging and inflated medicine prices were recurring public concerns... Full

 

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