Monday, March 3, 2025

Viatris Rocked By Indore US Block, With $500M Revenue Sting Anticipated In 2025

(2/28, Dean Rudge, Generics Bulletin) ...Viatris anticipates that half-a-billion dollars will disappear from its top line in 2025 on the back of the recent import alert for its oral solids facility in Indore, with much of the pain being caused by the firm's failure to have its generic version of Revlimid exempt from the restrictions... Global Sub. Full

Biocon Marks GLP-1 Milestone With UK Liraglutide Launch

(2/28, Dave Wallace, Generics Bulletin) ...The GLP-1 peptide will be marketed under the name Liraglutide Biocon for diabetes – referencing Victoza – and will be called Biolide for chronic weight management, equivalent to Saxenda. Launch of the drug-device combination product comes after Biocon almost a year ago received approval from the UK's Medicines and Healthcare Products Regulatory Agency for its liraglutide generic, which the company described as "testament to the company's strong focus on GLPs and peptides as important future growth drivers for the generics business."... Global Sub. Full

India's Sun Pharma Aims to Launch its Obesity Drug in Five Years, Managing Director Says

(3/3, Rishika Sadam, Reuters) ...India's largest drugmaker by revenue Sun Pharmaceutical is aiming to launch its experimental anti-obesity and type 2 diabetes drug in the next four to five years, Managing Director Dilip Shanghvi said on Friday...Sun Pharma's push into this category comes after companies such as Novo Nordisk and Eli Lilly saw skyrocketing demand for their weight-loss drugs Wegovy and Zepbound, which boosted the drugmakers' valuations... Full

AbbVie Finally Enters Obesity Race with $350M Upfront for Gubra's Amylin

(3/3, Kyle LaHucik, Endpoints News) ...AbbVie said Monday morning it's making the leap into the obesity field for the first time, by way of linking arms with a Danish biotech for $350 million upfront and up to $1.87 billion in development, commercial and sales biobucks for a long-acting amylin analog. Its new Danish partner is not the famed Wegovy maker Novo Nordisk, whose semaglutide and amylin combo disappointed investors at the end of 2024. Nor is it fellow Danish drugmaker Zealand Pharma, which is still searching for a Phase 3 partner for its own amylin analog... Full

Glenmark Pharma Arm Acquires and Launches Acetylcysteine Injection in US

(3/3, CNBC TV-18) ...This new product will be available in the strength of 6 gm/30 mL (200 mg/mL) single-dose vials in the US market, marking an expansion of Glenmark's injectable portfolio. The newly-launched acetylcysteine injection is expected to deliver the same therapeutic effects as the branded drug product, acetadote injection, 6 gm/30 mL (200 mg/mL) single-dose vials, which is manufactured by Cumberland Pharmaceuticals Inc, Glenmark informed the stock exchanges... Full

GSK Gears Up for Depemokimab Debut with Twin FDA Filings and Phase 3 Data Dump

(3/3, Darren Incorvaia, Fierce Biotech) ...With Sunday's Academy Awards ceremony in the rearview mirror, GSK is looking ahead to a potential blockbuster premiere of its own. The British Big Pharma has filed depemokimab for FDA approval in two respiratory indications on the back of new phase 3 data showing the antibody improved disease symptoms and quality of life in patients with chronic rhinosinusitis with nasal polyps (CRSwNP)... Full

Asthma Drug Showed Positive Results in Trials for People with Nasal Polyps

(3/2, Ryan McDougall, Independent) ...Tezepelumab was first approved for treating asthma in 2021, but new research led by a University of Dundee professor has found it also reduces the size of nasal polyps and nasal blockages. The results, published in the New England Journal of Medicine, say significant results were reported by users in as little as two-to-four weeks, compared with those who were given a placebo. Other outcomes were reported, including improved smell and quality of life, and underlying sinus problems were also alleviated in some individuals... Full

CHMP Recommends Regeneron, Novartis Drugs that Still Await FDA Approval

(2/28, Anna Brown, Endpoints News) ...The European Medicines Agency's human medicines committee (CHMP) has recommended four new drugs for approval, including Regeneron's Lynozyfic for the treatment of relapsed and refractory multiple myeloma...CHMP also suggested that the European Commission approve Krystal Biotech's Vyjuvek for the treatment of wounds in patients with dystrophic epidermolysis bullosa, a genetic skin condition. The other recommendations were for Accord Healthcare's generic trabectedin and Takeda's immunoglobulin drug Deqsiga... Full

AstraZeneca Pharma India Gets CDSCO Approval to Import, Sell Cancer Treatment Medicine

(3/3, Press Trust Of India) ...The approval by the Central Drugs Standard Control Organisation (CDSCO), Directorate General of Health Services, Government of India is for import, for sale and distribution of Durvalumab solution for infusion 120 mg/2.4 ml and 500 mg/10 ml (Imfinzi) for an additional indication, the company said in a regulatory filing... Full

Glenmark Pharma Recalls 15 Lakh Bottles Of ADHD Medication In US: FDA

(3/2, Press Trust Of India) ...The company is recalling the affected lot due to 'CGMP Deviations', the US health regulator said in its latest Enforcement Report. The recall is due to the "presence of N-Nitroso Atomoxetine impurity above the FDA-recommended limit", it added... Full

SmithRx Introduces Stelara Biosimilars to Its Autoimmune Program, Helping Clients Save a Projected $14.5M in Prescription Drug Costs

(2/28, SmithRx) ...SmithRx, a transparent, 100% pass-through modern pharmacy benefits manager (PBM), today announced a major expansion to its Connect 360 Autoimmune Program, including the introduction of Stelara biosimilars to its offering, new low-cost Humira and Stelara biosimilars for pediatric members, and a partnership with Costco Specialty Pharmacy alongside its long-standing relationship with Mark Cuban Cost Plus Drugs... Full

At Least Seven Drugmakers Say They Will Participate in Round Two of IRA Negotiations 

(2/28, Nicole DeFeudis, Endpoints News) ...Amgen, Boehringer Ingelheim, AstraZeneca, Astellas, Bristol Myers Squibb, Teva and GSK have signed agreements with CMS to participate, Endpoints News has learned. The companies will negotiate eight of the 15 drugs selected by CMS...A Novo Nordisk spokesperson said the company will "remain committed to working with new agency leadership to advance meaningful solutions for patients," but did not directly answer whether it has agreed to participate in negotiations... Full

Bipartisan 'Pill Penalty' Fix and Other Bills Vie for Inclusion in Reconciliation Package

(2/28, Zachary Brennan, Endpoints News) ...PhRMA and a nonprofit backing venture capital firms, known as Incubate, are both throwing their weight behind a bipartisan bill reintroduced on Wednesday in the House that would close the gap in the Inflation Reduction Act between biologics and small molecule drugs when it comes to how soon the negotiations can begin... Full

Trump's 'America First' Investment Policy Raises Uncertainty for US-China Biotech Dealmaking

(2/28, Angus Liu, Fierce Pharma) ...Trying to find common ground during a "Biotech Hangout" discussion in January about whether China's biotech growth should be curbed, TD Cowen analyst Yaron Weber argued that an increasingly innovative China is not the end of the world "as long as we can license those drugs, launch [new companies] and bring that IP and then own the global commercial market." Now, a new policy from President Donald Trump, although yet to be fully fleshed out, could affect the U.S. biopharma industry's ability to maintain each of those conditions... Full

Pharmaceutical Tariffs Likely Raise Prices, But Would They Lead To Reshoring?

(3/3, Joshua P. Cohen, Forbes) ...The extent to which price hikes and deficient supply of certain pharmaceuticals would occur will depend on the kinds of medicines involved. Brand name medications originating from European countries, for instance, often have sufficient gross margins built into their pricing, so an additional 10% or 25% tariff wouldn't necessarily get passed on to hospitals, insurers and patients. In addition, the relatively large margins coupled with tariffs could make it attractive for some branded drug makers to reshore production. For generic drugs, on the other hand, tariffs are more likely to be passed on to end-users because lower gross margins make it less feasible for manufacturers to absorb the added cost... Full

RFK Jr. Orders HHS to End 'Extra-Statutory' Notice, Public Comment Process in Rulemaking

(2/28, Dave Muoio, Fierce Healthcare) ...Friday morning, the HHS uploaded a policy statement that is set to be published in the Federal Register on March 3. Bylined by the secretary, it says the department is no longer required to undergo a public comment period it typically observes following the publication of proposed rulemaking in "matters relating to agency management or personnel or to public property, loans, grants, benefits or contracts." The HHS' agencies and offices may follow the notice and comment status quo at their "discretion … but are not required to do so, except as otherwise required by law," RFK Jr. wrote... Full

Killing the PBMs Won't Save Drug Costs, Economist Says

(2/28, Allison Bell, BenefitsPRO) ...While policymakers should try to increase pharmacy benefit manager competition and PBM transparency, it probably won't have much effect on U.S. prescription drug costs, according to Matthew Fiedler..."PBM profits amount to only several percent of overall drug spending," Fiedler told House members at the hearing. "So, even eliminating those profits would only moderately reduce the overall cost of drug coverage. If policymakers want to achieve larger cost reductions, that would require reducing the prices received by other actors in the supply chain, especially manufacturers."... Sub. Req’d

CSRXP: Fabrizio Ward Survey Finds American Voters Overwhelming Hold Big Pharma Companies Responsible for High Drug Prices

(2/28, The Campaign for Sustainable Rx Pricing) ..."Results from the new national survey of voters just completed for the Campaign for Sustainable Rx Pricing show broad and overwhelmingly bipartisan support for policy solutions to lower the cost of prescription drugs by addressing pricing and anti-competitive practices from drug companies," pollsters Tony Fabrizio and Bob Ward wrote in a memo on their findings. "The electorate, including equal numbers of Trump and Harris Voters, holds intensely unfavorable views of drug companies. By wide margins, voters are very concerned about the cost of Rx drugs, hold drug companies responsible, and clearly identify drug company profits as the driver of high drug costs."... Full

CVS Escapes Defunct Hospital's Antitrust Suit Over Drug Pricing

(2/28, Katie Arcieri, Bloomberg Law) ...CVS Health Corp. convinced a judge to toss antitrust claims brought by a former hospital that alleges the company forced it to purchase services from its Wellpartner subsidiary in order to gain drug price savings through a federal program... Sub. Req’d

Controlled Correspondence: FDA Offers Advice for Generic Sponsors

(2/28, Joanne S. Eglovitch, Regulatory Focus) ...US Food and Drug Administration officials discussed when it is best for applicants to submit a controlled correspondence or request a pre-ANDA meeting for questions related to their generic drug applications at a Thursday meeting sponsored by the CDER Small Business and Industry Assistance (SBIA). They also addressed the best ways of framing questions during a controlled correspondence to ensure they are answered the first time around... Full

FDA's Inspections of Foreign Drug Manufacturers Remain Challenged: GAO

(2/28, Greg Slabodkin, Pharma Manufacturing) ...While the FDA has made efforts to recruit and retain drug investigators who conduct inspections in foreign countries, the agency's capacity to conduct such inspections remains challenged, according to the updated High Risk List released this week by the Government Accountability Office... Full

Editorial: Another Layer of Bureaucracy isn't the Answer for Beleaguered Pharmacies, Gov. Pritzker

(3/3, Chicago Tribune) ... And as for solving the problem of high drug costs, Pritzker's proposal for a new bureaucracy empowered to set maximum prices faces a rocky road in Illinois and in other states that are trying it. With his "Prescription Drug Affordability Act," Pritzker envisions a blue-ribbon panel prying profits away from PBMs by capping prescription prices. But it's unclear who would benefit in this highly integrated marketplace if a nanny state were to intervene... Full

Florida Seeks Personal Prescription Data From Drug Middlemen

(2/28, John Tozzi, Bloomberg) ...Florida insurance regulators have asked companies to hand over extensive amounts of data on people's pharmacy claims, including personal information and prescription drug usage, an unusual move for a state regulator that's raising privacy concerns...The state asked for files that contained people's names, dates of birth, the drug that was dispensed, the provider who prescribed the medication and the pharmacy that dispensed it, among many other data fields... Full

After Near Miss, Ohioans Help Lead Charge to Rein in Drug Middlemen

(3/3, Marty Schladen, Ohio Capital Journal) ...In the past two weeks, Ohio leaders have been out front in a bipartisan effort to impose the strictest rules yet on pharmacy middlemen said to be using anticompetitive practices to drive up the price of drugs and to drive pharmacies out of business. State Attorney General Dave Yost and U.S. Rep. Troy Balderson, R-Zanesville, are calling for continued efforts at reform... Full

New Brief: ‘Maximum Fair Price' Policy Would Bring New Costs to Nevada Taxpayers, Put Patient Access to Health Care at Risk

(2/27, Wayne H Winegarden, PRI) ...Nevada taxpayers could face millions in new bureaucratic costs and patients will likely see less access to life-saving drugs if state government mandates so-called "Maximum Fair Price" price controls on prescription drugs, finds a new brief released today by the Center for Medical Economics and Innovation at the nonpartisan, California-based, free-market think tank, the Pacific Research Institute... Full

EMA Revises Acute Respiratory Distress Syndrome Expectations: Impact On Trial Patient Selection

(2/28, Vibha Sharma, Pink Sheet) ...The European Medicines Agency is consulting on new requirements in its guideline on clinical trials for acute respiratory distress syndrome. The updates cover the selection of target population, choice of endpoints, use of biomarkers and pandemic preparedness... Global Sub. Full

Trump Tariffs On Drugs: Five Ways it Could End, As Per Lupin Global CFO

(3/3, CNBC TV-18) ...Ramesh Swaminathan, Executive Director, Global CFO, and Head of Corporate Affairs at Lupin, noted that India's pharmaceutical industry has diversified beyond the US. The proposed 25% tariff on Indian pharmaceutical exports to the US has raised concerns about its impact on drug affordability and supply chains. Ramesh Swaminathan, Executive Director, Global CFO, and Head of Corporate Affairs at Lupin outlined five possible ways this situation could unfold... Full

Reciprocal Tariffs May Make Indian Generic Drugs Costlier in US: Pharma Giants On Trump Stance

(3/2, Vikas Dandekar, The Economic Times) ...Dilip Shanghvi, chairman and managing director at Sun Pharma, India's largest drug maker by sales and market cap, told an industry gathering that his company sells products between $1 and $5 per bottle in the US and a tariff of 10% or 25% may marginally change that cost. "Possibly it will not justify relocating manufacturing," Shanghvi said, responding to Trump's frenetic calls to either set up manufacturing bases in the US or face tariffs. He added the profit margins for drugs sold in the US are so low that the ability to absorb tariffs is limited... Full

Note: Article links may expire over time or require a free registration. All news articles are the property of their respective publishers and copyright holders. [contextual emphasis added].

Teva global subscription access: registration is required to access FirstWord Pharma+ News and The Generics Bulletin. Please note you must be on the Teva Network (in a Teva location or connected via VPN) to access Teva's InfoNOW news resources. If you have any questions or issues, please email InfoNOW@tevapharm.com.

 

•      FirstWord Pharma+ News registration: first-time users, register here with your Teva email address. You will automatically receive a daily FirstWord Pharma+ newsletter; click on any news item to access your account.

•      Generics Bulletin, Pink Sheet, Scrip (Citeline) registration: go to the Generics Bulletin site and choose "Sign In" in the upper right-hand corner. First-time users, choose "Sign Up Here" and enter your Teva email address.