Thursday, April 24, 2025

Roche Sales Gain On Boost From Key Drugs Amid U.S. Production Push

(4/24, Helena Smolak, The Wall Street Journal) ...To strengthen its U.S. presence, Roche is building up inventory, ramping up production for three products at its U.S. manufacturing sites and transferring the production of a fourth product to those sites, its chief executive Thomas Schinecker said in a call with journalists. According to Schinecker, four of Roche's medicines account for up to 92% of the company's potential exposure to U.S. tariffs, though he declined to name the specific products... Sub. Req’d

Hikma Pharma Reaffirms FY25 Guidance Amid Strong Start

(4/24, RTT News) ...The company's Generics business is seeing steady demand, particularly for nasal and inhalation products. The company is strengthening its R&D capabilities, including a new Zagreb, Croatia R&D center, and advancing key development projects to expand its portfolio...Further, the company stated that it remains confident in its expanding US manufacturing footprint, which supplies the majority of its US sales. The company is closely monitoring tariff developments but has not factored any impact into its full-year outlook... Full

Sanofi's Quarterly Profit Boosted by Dupixent and Newer Drugs; Forecast Unchanged

(4/24, Manas Mishra, Reuters) ...France's Sanofi reported first-quarter profit that beat analysts' expectations on Thursday, boosted by strong demand for its anti-inflammatory drug Dupixent, as well as newer treatments and vaccines...Sanofi results come as healthcare investors brace for potential tariffs by U.S. President Donald Trump on the sector after his administration announced probes into imports of pharmaceuticals. CFO Roger said at a press briefing that the company, which has been increasing its manufacturing presence in the United States, would consider more investments in the US, based on future needs... Full

Bristol Myers Posts Better-Than-Expected Quarterly Revenue On Strong Cancer Drug Sales

(4/24, Michael Erman, Reuters) ...Bristol Myers Squibb reported better-than-expected first-quarter revenue on Thursday and raised its full-year forecast due to growth from its portfolio of drugs that spur a patient's own immune system to fight cancer. The company's shares have dropped more than 20% over the past month as investor concerns about U.S. President Donald Trump's tariff threats have roiled the markets. Chief Financial Officer David Elkins said in an interview that the company's global manufacturing footprint puts it in a good position to deal with whatever tariffs may come... Full

Merck Posts Higher Profit, Puts Tariffs Cost at $200 Million

(4/24, Deena Beasley, Reuters) ...Merck on Thursday said its first-quarter adjusted profit rose 7% as lower costs helped offset a 2% decline in sales, reflecting a January decision to pause shipments of its Gardasil vaccine to China due to a downturn in demand. For the full year, Merck lowered its earnings outlook slightly, citing an estimated $200 million in additional costs for tariffs implemented to date and a charge related to a licensing deal with Hengrui Pharma... Full

Novo Nordisk's Stellar Wegovy-Fuelled Run of Hiking Sales Guidance Could Be Ending

(4/24, Maggie Fick, Reuters) ...Concerns about how Novo is faring against Lilly in the fiercely competitive obesity drug market and disappointing trial data for its next-generation drug CagriSema have wiped $230 billion, or 45%, off its market value since early December. Some analysts expect prescriptions of Wegovy and Ozempic to recover after the U.S. Food and Drug Administration (FDA) enforces a ban on copies, which Novo says could redirect demand to its own products... Full

Sunshine Becomes Latest To Compete On Everolimus In Canada

(4/23, Dave Wallace, Generics Bulletin) ...Sunshine Biopharma is continuing to push forward with new generics launches in Canada, this time adding to competition for Novartis' Afinitor (everolimus) in the market by rolling out everolimus tablets in 2.5mg, 5mg, and 10mg strengths...According to Health Canada's database of approved drugs, other firms holding approvals in the country for everolimus tablets in those strengths – as well as the 7.5mg strength – include Dr Reddy's, Natco, Pharmascience, Sandoz and Teva. Pharmascience had announced its own Canadian launch of 2.5mg, 5mg and 10mg everolimus tablets back in 2021... Global Sub. Full

Hikma Secures US Rights To Novugen's Generic Trametinib

(4/23, Adam Zamecnik, Generics Bulletin) ...Hikma Pharmaceuticals has struck a deal with Novugen to acquire its first-to-file abbreviated new drug application for anti-cancer therapy trametinib, paving the way to the coveted 180-day exclusivity status on the US generics market for the US Food and Drug Administration-approved product... Global Sub. Full

Sanofi's Oral TNF Inhibitor Misses Mark in Phase 2 Psoriasis Trial, Prompting Focus On Combos

(4/24, Nick Paul Taylor, Fierce Biotech) ...Sanofi's development of an oral spin on Humira's mechanism has hit a setback. The candidate fell short in a phase 2 psoriasis trial, prompting the French drugmaker to pull back from plans to develop the molecule as a monotherapy...Sanofi expects to publish phase 2 data on balinatunfib in rheumatoid arthritis in the second half of 2025. The readout could confirm the small molecule has a profile that is suitable for further development in combinations. Sanofi noted in this morning's earnings presentation that rheumatoid arthritis is "already a combination market." Sanofi recently began phase 2 trials in Crohn's disease and ulcerative colitis... Full

Lupin Shares Gain 3% After USFDA Approval for $1.5 Billion Drug, 180-Day Exclusivity

(4/24, Vinnii Motiwala and Shloka Badkar, CNBC TV-18) ...Lupin is the first to file for this product and is eligible for 180 days of generic drug exclusivity. The product will be manufactured at Lupin's Nagpur facility in India and will be launched soon, the company said in its exchange filing. Tolvaptan tablet is the bioequivalent of Jynarque tablets of Otsuka Pharmaceutical Company...Analysts said Lupin is expected to be the only generic player for this during most of the financial year 2026. It has a revenue opportunity of around $150 million to $200 million this year, analysts estimated... Full

GLP-1 Drugs Will Provide Significant Tailwinds for Drug Distributors

(4/24, The Pharma Letter) ...Drug distributors like Cardinal Health, Cencora and McKesson will play a key role in the drug supply chain, improving patient access to healthcare, according to Morningstar. The financial services company newly published "US Drug Distribution Industry Landscape" report, indicates that GLP-1 drugs will continue to drive growth for these companies in 2025, but the decline in generic drug prices weighs down distributors' margins... Sub. Req’d

GOP Launches Caucus to Promote Medicine Production in America

(4/24, Erin Durkin, Bloomberg) ...Rep. Buddy Carter (R-Ga.), health chair on the House Energy and Commerce Committee, will announce the American-Made Medicines Caucus along with Reps. Claudia Tenney (R-N.Y.) and Gus Bilirakis (R-Fla.). The group of lawmakers will focus on ways to bring the pharmaceutical supply chain to the US and be less dependent on nations like China for pharmaceutical products... Sub. Req’d

Tariff Hits to Generic Drugs Could 'Blow Back On Everybody' Without Supply Chain Resilience, Says USP Chief

(4/23, Fraiser Kansteiner, Fierce Pharma) ...While much of the conversation around the Trump administration's potential pharmaceutical import tariffs has leaned heavily toward branded drugmakers, generic medicines and the companies that manufacture them will be uniquely vulnerable in the event of a trade war given just how "little resilience" the industry enjoys compared to its patented counterpart. That's the take according to Ronald Piervincenzi, Ph.D., CEO of the United States Pharmacopeia (USP)... Full

Roche Seeks US Tariff Relief in Direct Talks with Trump Administration

(4/24, Ludwig Burger, Reuters) ...Swiss drugmaker Roche is petitioning the U.S. government in direct talks for import tariff exemptions, arguing the products it ships into the United States are offset by its exports of U.S.-made drugs and diagnostics. "As long as we produce the same amount in the U.S. as we import... we would not be impacted by tariffs. That's kind of the discussion we are trying to have with the U.S. government," CEO Thomas Schinecker said in a media call after the release of first-quarter sales figures... Full

Tariffs Will Make Financial Case for Pharma M&A ‘More Difficult,' Says Roche CEO

(4/24, James Waldron, Fierce Biotech) ...Big Pharma's M&A plans will likely take a hit if the U.S. government under the President Trump administration lives up to its threats of imposing tariffs on the industry, Roche's CEO has warned. In a first-quarter earnings call with journalists Thursday morning, Thomas Schinecker said that for now, the Swiss pharma's mantra for finding new acquisitions continues to be: "Does the deal make financial sense?" But Schinecker added that if pharmaceutical tariffs do come into the force then the industry will find it "more difficult to make financial sense of any M&A deals."... Full

Trade War with China to Hit US Healthcare

(4/23, Andy Hirschfeld, Al Jazeera) ...India supplies about half of all generic drugs used in the US. However, it depends on China for 80 percent of its active pharmaceutical ingredients (APIs), the chemical compounds medications are made from. One of the globe's biggest pharmaceutical giants said it worries any tariff would drive up prices and hurt patient care. In a shareholder meeting, Michel Demare, chairman of the board for AstraZeneca, said, "We still strongly believe that medicines should be exempted from any kind of tariffs because, at the end, it is just harming patients' health systems and restricting health equity."... Full

NAHPC Exec Hopes Trump EO Leads To Clarity On PBM Fiduciary Responsibility

(4/23, Gabrielle Wanneh, Inside Health Policy) ...Shawn Gremminger, president and CEO of the National Alliance of Healthcare Purchaser Coalitions (NAHPC), told Inside Health Policy that Trump's recent drug-pricing executive order calling for the PBM reform could lead to the government establishing the fiduciary duty for PBMs and other third-party entities under the Employee Retirement Income Security Act (ERISA)... Sub. Req’d

Trump's HHS Rejects PhRMA's Challenge to Drug Price Excise Tax

(4/23, Nyah Phengsitthy, Bloomberg Law) ...The US Department of Health and Human Services said the Pharmaceutical Research and Manufacturers of America and two other health associations fail to prove that the government's excise tax on drugmakers violates the Eighth Amendment's prohibition on excessive fines, which forces them to comply with the drug program... Sub. Req’d

Major Pharma, Tobacco Critic Dick Durbin To Retire From Congress

(4/23, Jessica Karins, Inside Health Policy) ...Senate Democratic Whip Dick Durbin (D-IL), a longtime advocate for reducing drug prices and the author of the 2009 law giving FDA authority to regulate tobacco, has announced he will not seek reelection for another term in 2026...His retirement will open up a leadership position on the Judiciary Committee, where he held hearings targeting both drug makers and pharmaceutical benefit managers for what he said were policies driving up drug costs... Sub. Req’d

Key FDA Drug Data Goes Missing Amid DOGE Cuts

(4/24, Tina Reed, Axios) ...The FDA not only reviews drugs for safety and efficacy but acts as a nerve center churning out information in real time when there are adverse events, quality problems or drug shortages. But in several recent instances, current and former officials said, databases didn't get updated promptly or were missing key information because there were no employees to maintain them...Experts say the databases are heavily used — and that the idea they might have outdated information is alarming... Full

OGD's Policy Office Cut To Have ‘Profound' Impact On New Generic Approvals, Warns Former FDA Head Gottlieb

(4/23, Urte Fultinaviciute, Generics Bulletin) ...The elimination of the policy division at the Office of Generic Drugs, tariffs, the Section 232 investigation, and a new executive order to promote lower drug prices seem to both cause and purport to solve the same problem: supply chain disruption...The changes are set to be especially disruptive for the generic drug industry, as amidst the tsunami of reduction-in-force terminations, the agency said goodbye to the policy division in the Office of Generic Drugs... Global Sub. Full

Vanda Sues FDA Over Hearing Delay as Agency Points to Mass Layoffs, Other Litigation with the Biopharma

(4/23, Gabrielle Masson, Fierce Biotech) ...Vanda has filed a lawsuit against the federal agency for the "unlawful delay" that is currently pending in Washington, D.C., courts, a Vanda spokesperson told Fierce. The drug at the heart of the dispute is tradipitant, an investigational NK-1R antagonist that the FDA rejected as a gastroparesis treatment in September 2024. At the time, Vanda CEO Mihael Polymeropoulos, M.D., argued that the CRL generally disregarded the evidence the company had provided to support the application... Full

EU Pharma Seeks Reform Amid Trade Risks

(4/23, Manuela Callari, Medscape) ...The EU is also considering a patent package to create a unified system for supplementary protection certificates across most EU countries. This would make it easier and cheaper for companies to protect their inventions in Europe. However, the package also includes new rules for compulsory licensing, which would allow governments to override patent protections during emergencies. While this could improve access to medicines in a crisis, Savli said the industry is concerned that it would affect innovation and the rights of patent holders... Full

EU Holds Firm On Pharma Reform Proposal Despite Industry Pressure

(4/23, Gerardo Fortuna, Euronews) ...The EU executive remains optimistic about reaching a positive outcome through ongoing negotiations with lawmakers in the review of the bloc's pharmaceutical framework and won't alter the original proposal despite requests from the European pharmaceutical sector... Full

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