Thursday, April 3, 2025

Wockhardt Pins US Future on Novel Antibiotics, Vacating US Generics Biz

(4/3, Ranjani Raghavan and Jessica Jani, Mint) ...The company is working on new antibiotics and has identified segments for a push into biosimilar drugs, chairman Habil Khorakiwala said, in the wake of promising results shown by Zaynich, an antibiotic it developed in-house...The company is building a global business model for its drug discovery and research business, targeting a 10-year exclusivity in the regulated markets for its novel antibiotics, and new biosimilar drugs to treat diabetes and obesity, said Khorakiwala..."I want to derisk the organization fundamentally," Khorakiwala said in an interview. "You will see a (new) drug coming out of our portfolio every two years for the next five to seven years."... Full

Roche Fails in Bid to Increase Dose of MS Drug Ocrevus

(4/2, Reuters) ...Roche said on Wednesday that a trial testing higher doses of its multiple sclerosis drug Ocrevus did not show an efficacy benefit over the standard dose, a setback in a bid to further boost usage of the best-selling therapy. The late-stage study showed no additional benefit of a two or three times higher dosage than the standard 600 mg version in slowing disability progression of relapsing multiple sclerosis, the Swiss drugmaker said... Full

US Uncertainty Casts Shadow over Boehringer's Pipeline Progress

(4/2, Matthew Dennis, FirstWord Pharma) ...Boehringer Ingelheim expects "a slight" rise in sales in 2025, as "the general trends and developments" of the past year are set to continue. However, uncertainty remains over the US market — given the potential of incoming tariffs, which are expected to be announced by the Trump administration on Wednesday. "We don't even know whether there are going to be tariffs," remarked chairman Hubertus von Baumbach, adding "we are not falling prey…to a noise which we haven't even been able to separate from the facts yet."... Sub. Req’d

Organon Looks To Tap Tocilizumab Potential Following Biogen Acquisition

(4/2, Dean Rudge, Generics Bulletin) ...Under the terms of the agreement, Organon has bought regulatory and commercial rights to Tofidence for intravenous infusion – the first tocilizumab biosimilar approved by the US Food and Drug Administration – which is currently available in three vial sizes: 80mg/4ml, 200mg/10m, and 400mg/20m... Global Sub. Full

Primary Care Firm Knownwell Joins LillyDirect to Offer Weight-Management Services

(4/2, Reuters) ...Patients on LillyDirect will have access to physicians from knownwell for personalized services, knownwell said. The company offers in-person and virtual primary care, nutrition counseling and behavioral health services, covered through patients' insurance... Full

Hims & Hers Zepbound Offering Won't Bring Needed Sales Boom, Analysts Say

(4/2, Katherine Hamilton, The Wall Street Journal) ...Hims & Hers has been selling a compound GLP-1 for around $165 a month, but will now offer the brand-name Zepbound for around $1,900 a month. Investors worry patients won't make that price leap and that Hims, which has built its business on affordable healthcare, will struggle to meet its revenue goal... Sub. Req’d

Bevacizumab Biosimilars Reduce Costs While Maintaining Survival Outcomes in mCRC

(4/2, Deana Ferreri, PhD, Center for Biosimilars) ...The researchers said the 2 biosimilars were cost-effective "at all conventional willingness-to-pay thresholds, indicating the importance and value of biosimilars for improved health system sustainability." The real-world, 1-year cost savings associated with the use of one of these biosimilars for 1 patient was $6379 CAD. The authors noted that the economic burden of cancer treatment is growing, largely driven by the costs of biologic drugs, such as bevacizumab, an antibody targeting vascular endothelial growth factor, an inducer of angiogenesis... Full

Pharma Stocks Climb on US Tariff Exemption, but Uncertainty Continues

(4/3, Maggie Fick and Kashish Tandon, Reuters) ...Many in the industry predicted the recent uncertainty over tariffs would continue to cast a shadow over pharma companies. "I think the only thing that feels certain is more uncertainty," Barclays analyst Emily Field told Reuters. "There is no sense of relief really," said one source at a European drugmaker. The sense on pharma sector tariffs, the source said, was: "It's not today, but it's coming."... Full

Trump Signs Orders Imposing 10% Minimum Tariff, Broader Reciprocal Tariffs—but Exemptions for Pharma

(4/2, Dave Muoio, Fierce Healthcare) ...A 39% European Union tariff rate, for instance, will be matched by a 20% rate, the president explained. A 67% tariff imposed by China will see a reciprocal 34% tariff from the U.S. Pharmaceuticals are among a select list of goods that will not be subject to the higher reciprocal tariffs, according to a fact sheet released shortly after the signing ceremony and affirmed in the signed executive order. The president also signed an order to close the "de minimis loophole," a trade policy signed into law by Congress that allows shipments valued at less than $800 to be duty-free, for Chinese imports... Full

Drugmakers Scramble to Decode True Impact of Trump's New Tariff Plan

(4/3, Anna Bratulic, FirstWord PHARMA) ...While the White House fact sheet lists pharmaceutical products among several categories that will "not be subject to the Reciprocal Tariff," Trump specifically mentioned in his remarks Wednesday that pharma companies will "come roaring back" to the US "because if they don't, they got a big tax to pay," suggesting the industry remains in his crosshairs. "We're going to produce the… medicines that we need right here in America," he added, highlighting that the US "no longer produces enough antibiotics to treat our sick."... Sub. Req’d

As Trump's 'Liberation Day' Tariffs Seem to Spare Pharmaceuticals, Threat of Industry-Specific Duties and Loopholes Persists

(4/2, Fraiser Kansteiner, FiercePharma) ..."The devil is a little bit in the details," Jeff Stoll, U.S. national strategy life sciences leader at the professional services outfit KPMG, said in a recent interview with Fierce Pharma. If active pharmaceutical ingredients (API)—versus finished drugs—are excluded from the "pharmaceutical" language of the fact sheet, for instance, then many of the industry's concerns about trade barriers would still hold water. "If APIs are still tariffed, generic drugs and the ability to produce them at low cost would be impacted," Stoll explained. "So, the big question is ultimately where do the tariffs start or end. If the tariffs are on the pieces that come together to make drugs, such as API, that will have an impact on costs."... Full

Chaotic Tariff Rollout Leaves as Many Questions as Answers for Drugmakers

(4/2, Max Bayer, Endpoints News) ...The 37-page annex still might not provide complete clarity to pharma companies trying to figure out what is and what isn't included. "People have to make decisions tomorrow and it's not going to be clear," Dan Harris, an international business lawyer at Harris Sliwoski in Seattle, told Endpoints... Sub. Req’d

Drug and Device Makers Confront Trump Tariffs

(4/3, Adriel Bettelheim, Axios) ...[T]he actions announced Tuesday could dramatically raise industry costs and force drug and med tech companies to rethink their supply chains, find alternative strategies for sourcing raw materials and look for ways to increase cash flow... Sub. Req’d

FDA Cuts Stir Buyer's Remorse for Some Biopharma Leaders, Once Excited by Trump

(4/3, Andrew Dunn and Max Bayer, Endpoints News) ..."I'm not a drama queen, but I'm really frightened by where we're going," Greg Kunst, who until recently was the CEO of cell therapy startup Aurion Biotech, said in an interview with Endpoints News. Kunst, a Republican, voted for Trump — though now says he regrets it. He said he's most alarmed by the recent FDA cuts and the departure of Peter Marks, the director of the Center for Biologics Evaluation and Research... Sub. Req’d

Key FDA Officials From Generics And Biosimilars User Fee Programs Laid Off, Said AAM

(4/3, Urte Fultinaviciute, Generics Bulletin) ...While the US off-patent drug trade group supported improving the FDA's efficiency to deliver more affordable medicines, it said that many of the reported cuts did the opposite. The AAM did not name the exact staff who were laid off. The layoffs will also "severely and broadly impact patient care" as the agency's expertise and capacity to review and approve generics and biosimilars have been decreased, the AAM cautioned... Global Sub. Full 

Drug Industry Worries About FDA Delays

(4/3, Tina Reed, Axios) ...As yet, there have been no delays to drug approvals, but industry watchers worry that may not last in light of the agency job cuts. On Wednesday, CBS News reported the FDA is planning fewer food and drug inspections as a result of reductions in the FDA's Office of Inspections and Investigations. Potential delays would not only be costly to drug makers, particularly smaller manufacturers, but can drive up prices for patients waiting for innovative treatments, experts say... Sub. Req’d

Editorial: The Wrong Prescription for HHS

(4/3, The Washington Post) ...The Trump administration has shown great skill at "moving fast and breaking things," to borrow the motto used by chief bureaucracy smasher Elon Musk. But Trump and Kennedy should remember, too, that when "you break it, you buy it." The damage they do to the country's public health and biomedical research infrastructure is their responsibility, and they will bear the political consequences... Sub. Req’d

Day After Mass FDA Firings, New Commissioner Addresses Remaining Staff, Focusing on 'MAHA' Vision

(4/3, Zachary Brennan, Endpoints News) ...Two of the people said that Makary laid out a focus of the agency that closely matches Kennedy's MAHA policies. He particularly focused on chronic diseases and bringing new viewpoints and arguments into government scientific agencies, while repeatedly emphasizing a need for humility. He also spoke about the importance of gene therapies and bringing new medicines to the public, despite the reportedly forced resignation of Peter Marks, one of its biggest advocates for gene editing technology and other advanced therapies... Sub. Req’d

The Emerging Health Communications Gulf

(4/3, Maya Goldman, Eleanor Hawkins, Alison Snyder, Axios) ...These layoffs — particularly those within the FDA — could also affect corporate America by making drug manufacturers, food providers and retailers more prone to legal and reputational risk... Sub. Req’d

Amid Challenges, an Opportunity for PBMs To Do Business Differently, Says PCMA Leader | AMCP Annual 2025

(4/2, Logan Lutton, Managed Healthcare Executive) ...Pharmacy benefit managers (PBMs) face a variety of challenges and must balance increasing pressure from markets, consumers and an evolving policy landscape, Juan Carlos Scott, president and CEO of the Pharmaceutical Care Management Association (PCMA), said at the Academy of Managed Care Pharmacy annual meeting today in Houston. "The combination of increasing cost, demand and political activity creates an environment that's really ripe for disruption and change and also opportunity to think about how we do the business of PBM differently," Scott said... Full

AbbVie Fights Mississippi Drug Discount Law at Fifth Circuit

(4/2, Ganny Belloni and Nyah Phengsitthy, Bloomberg Law) ...AbbVie Inc. appeared to find a sympathetic listener as it urged a three-judge panel Wednesday to block a Mississippi statute that requires manufacturers to steeply discount medicines to an unlimited number of pharmacies that are under a federal drug discount program... Sub. Req’d

Fired FTC Commissioners Say Stay In PBM Case Was ‘Foreseeable Consequence' Of Firings

(4/2, Sigi Ris, Inside Health Policy) ..."Sadly, this was an entirely foreseeable consequence of illegally attempting to fire the minority Commissioners," Slaughter and Bedoya said in a joint statement Tuesday (April 1), the same day FTC moved for an expedited order to stay the administrative proceeding. "The American people deserve a fair and timely adjudication of the serious allegations in the FTC's complaint," the former commissioners added. "We strongly object to the pause in this matter. Here, justice delayed will be justice denied. It is hard to think of a matter that is more important."... Sub. Req’d

It Is Time to Break up The PBM Monopoly in Indiana State Sen. Andy Zay

(4/2, The Shelbyville News) ...In 2023, House Enrolled Act 1445 secured an audit of the state's $2 billion spend on pharmacy benefit services. Completed by RxConnection, the audit successfully shed light on the chaos caused by PBMs involved in our state's prescription drug coverage plans. The audit summary revealed many issues within the execution of Indiana's coverage plans, which are listed below... Full

Biosimilars Forum Supports the FDA, Its Employees, and Its Mission

(4/2, Biosimilar Forum) ..."A well-resourced and stable FDA is necessary to ensure that Americans have access to safe and effective medicines, like lower-cost biosimilars. The Biosimilars Forum is concerned that reductions in critical FDA personnel risk losing the institutional knowledge and expertise needed to fulfill the agency's mission. The reductions in force at the FDA —and the loss of the qualified and dedicated staff who fulfill its mission—risk harming Americans that need healthcare... Full

Pharma's Exemption from Reciprocal Tariffs Underscores Generic Medicines' Critical Role Globally

(4/3, The Economic Times) ...The US administration has exempted pharmaceuticals from reciprocal tariffs, underscoring the critical role played by generic medicines globally, Indian Pharmaceutical Alliance (IPA) Secretary General Sudarshan Jain said on Thursday. President Donald Trump, in a historic measure to counter higher duties on American products imposed globally, on Wednesday announced reciprocal tariffs on about 60 countries. He announced 27 per cent reciprocal tariffs on India, saying New Delhi imposes high import duties on American goods... Full

Trump Skipping Pharma Tariffs Buoys Sector Stocks in India

(4/3, Kosaku Narioka, Dow Jones) ...Trump didn't announce pharmaceutical tariffs when he unveiled the latest U.S. trade plans on Wednesday, and language in the executive order indicated that medicines were exempt from the reciprocal tariffs. Trump had said he was going to impose pharmaceutical tariffs at some point --a move that could affect the many generic drugs made in India as well as branded medicines imported from countries like Ireland... Full

India's API Industry at a Key Juncture, Guided by Global Supply Chain Dynamics & Shifting Regulatory Landscape

(4/3, Nandita Vijayasimha, Pharmabiz.com) ...To combat supply chain risks, Indian API manufacturers are investing in the domestic production of intermediates and KSMs. This will reduce the reliance on imports and ensure a cost-competitive, stable supply chain. Some of the larger pharma players are establishing Greenfield API plants to enable this transition. The market is moving away from commodity APIs to niche, high-margin segments like orphan & rare disease APIs with a growing focus on personalized medicine... Full

Branded Medicines Over Generic: How the Market Is Putting Patients in a Bind

(4/3, Yemen S., The Hindu) ...Doctors prescribing branded medication instead of general medicine to patients has been a persistent issue. Clause 1.5 of the Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002, prescribes that every physician should, as far as possible, prescribe drugs with generic names. It is to be written legibly and preferably in capital letters and he/she shall ensure that there is rational prescription and use of drug. Similarly, as per the Medical Council of India (MCI) guidelines (2016) and National Medical Commission (NMC) advisory (2022), doctors must prescribe medicines by their generic names rather than brand names... Full

Small-Town Ireland Nervous as Trump Seeks to Lure Pharma Investment to US

(4/3, Padraic Halpin and Maggie Fick, Reuters) ...A cluster of high-tech plants offering well-paid jobs - the product of Dublin's strategy of attracting multinationals with generous corporate tax policies - has transformed the southerly rural town, quadrupling its population in just two decades. The pharmaceutical industry has an outsized presence in Ireland, employing about 2% of the workforce and generating tens of billions of euros in taxes for government coffers... Full

BRICS Nations Offer ‘Counterbalance' to US Tariffs as Global Pharma Manufacturing Players

(4/2, Greg Slabodkin, Pharma Manufacturing) ...With Brazil, Russia, India, China, and South Africa (BRICS) nations exploring barrier-free regulations for biosimilars and biologics, these countries could provide a "counterbalance" to the challenges posed by U.S. tariffs "fostering healthy competition and reducing production costs," according to analytics firm GlobalData... Full

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