Friday, August 1, 2025

Teva: Not All Our Biosimilars Need To Be Superstars

(8/1, Dean Rudge, Generics Bulletin) ...With plans to launch 20 biosimilars and bring a total of eight to market by 2027, Teva says that not all its biosimilars need to be "superstars," as it remains confident of doubling 2024 biosimilar revenue to $800m in the next two years by using a "portfolio play." Addressing investors during Teva's second-quarter earnings call, the company's CEO Richard Francis emphasized that although each biosimilar launch has its own unique dynamics, the firm is confident in its team's ability to navigate market conditions, giving it a competitive edge in executing biosimilar launches... Global Sub. Full

Teva's Big Pharma Comeback: Why I Think The Market Is Still Missing The Upside

(7/31, Motti Sapir, Seeking Alpha) ...At under $17 a share, I see Teva as a perfect example of a company that's turning the corner—just as the market is still looking in the rearview mirror. To me, the big opportunity here is that the numbers are starting to show real progress but the stock price is still stuck in the mud. Teva's valuation is low enough that it feels like investors are expecting more bad news, when in reality, the business is actually picking up steam. I think this is a pretty typical situation where people need proof—people want to see a couple more quarters before they believe it. But in my opinion, if you wait for the headlines to turn positive, you'll miss most of the upside. So for me, this is a Buy... Full

Trump Demands Pharma CEOs Implement 'Most Favored Nation' Pricing Within 60 Days

(7/31, Drew Armstrong, Endpoints News) ...The letters were addressed to top executives at Pfizer, AbbVie, Boehringer Ingelheim, Novartis, Gilead, EMD Serono, Novo Nordisk, Bristol Myers Squibb, Amgen, Genentech, Johnson & Johnson, GSK, Merck, Regeneron, Sanofi, Eli Lilly and AstraZeneca...Endpoints News reached out to many of the companies that were named in the letters. Most didn't respond or declined to comment on the demands, though Pfizer said it had been talking with the administration and described those meetings as "productive," while Novo Nordisk said it would "continue to work to find solutions that help people access the medication they need."... Sub. Req’d

White House Threatens To 'Deploy Every Tool In Our Arsenal' To Implement Most-Favored-Nation Drug Pricing

(7/31, Fraiser Kansteiner, Fierce Pharma) ...Trump also urged the drugmakers to look for ways to cut out pharmacy benefit managers (PBMs) and sell their products directly to patients, so long as they don't do so at a higher cost than the best price available in the applicable reference countries. According to the text of the letter, if the targeted pharma companies "refuse to step up," the federal government "will deploy every tool in our arsenal to protect American families from continued abusive drug pricing practices," the White House noted in a fact sheet issued Thursday... Full

Trump Escalates Demands that Pharma Companies Lower Their Drug Prices

(7/31, Elaine Chen, STAT) ...The industry trade group PhRMA said that lowering U.S. drug prices as Trump demanded "would undermine American leadership, hurting patients and workers." "To reduce price differentials with other countries, policymakers should rein in health care middlemen driving up costs for Americans and get foreign countries to pay their fair share for innovative medicines," Alex Schriver, a PhRMA spokesman, said in a statement. The trade group BIO also said it opposes Trump's demand for price controls, and similarly pointed the finger at drug-industry middlemen... Full

Trump Again Demands Pharma CEOs Adopt Most Favored Nation Prices

(7/31, Maaisha Osman, Inside Health Policy) ...Peter Maybarduk, director of Public Citizen's Access to Medicines program, criticized Trump's latest letter as political posturing, telling Inside Health Policy the strategy appears designed to shift blame to foreign governments rather than enact real reform. "If President Trump wanted to lower drug prices, he'd work with Congress on the clear, well-established ways to strengthen price negotiations under law," Maybarduk said, dismissing the administration's ad hoc approach as lacking accountability and enforceable mechanisms... Sub. Req’d

Sun Pharma Says No Word Yet from US On Drug Pricing

(8/1, Ekta Batra, CNBC TV-18) ...Sun Pharmaceutical Industries, India's largest drugmaker, has not yet received any communication from the US administration regarding price parity demands for medicines, according to its Chief Financial Officer, Jayashree Satagopan. "As of now, we have not received any letters, and as and when there is a further development, we will be in a position to assess it for our speciality portfolio," she said... Full

PCMA Statement On Trump Administration's Actions to Lower Drug Prices for Americans

(7/31, PCMA) ..."PCMA commends the president for his continued commitment to lowering prescription drug prices. Americans are paying the highest prices in the world when it comes to prescriptions – and that's not right..."Drug companies alone set and raise drug prices and can lower the list prices at any time. In addition, some drug companies block lower cost generics and biosimilars from entering the market, leading to Americans paying the highest prescription drug prices in the world. We look forward to continuing to support the Administration's goal of making prescription drugs more accessible and affordable for Americans."... Full

Cassidy Drug Pricing Plan Stalled As Senate GOP Rejects MFN Approach

(7/31, Maaisha Osman, Inside Health Policy) ...Senate health committee Chair Bill Cassidy's (R-LA) proposal to penalize drugmakers that charge lower prices overseas is currently on hold, two people familiar with the matter told Inside Health Policy, as many Senate Republicans remain opposed to "most favored nation" (MFN) pricing policies -- even as President Donald Trump on Thursday (July 31) doubled down on his executive order to implement the policy... Sub. Req’d

New Tariffs Could Raise Prices of Ozempic, Wegovy

(7/31, Alix Martichoux, The Hill) ...Other name-brand drugs like Botox, Viagra and Keytruda (a cancer medication) are also manufactured in Europe and impacted by the tariffs. Some drug generics were supposed to be carved out of the deal, but details were still pending as of Thursday. When asked how Ozempic and Wegovy would be impacted by the new 15% tariff, a Novo Nordisk spokesperson told Nexstar the company "remains focused on improving patient access and affordability, and we will continue to work to find solutions that help people access the medication they need."... Full

Medicare, Medicaid Plans to Experiment with Covering Weight Loss Drugs

(8/1, Paige Winfield Cunningham, The Washington Post) ...Some obese Americans on Medicare and Medicaid could get access to expensive weight loss drugs under a five-year experiment being planned by the Trump administration. Under the proposed plan, state Medicaid programs and Medicare Part D insurance plans will be able to voluntarily choose to cover Ozempic, Wegovy, Mounjaro and Zepbound for patients for "weight management" purposes, according to Centers for Medicare and Medicaid Services documents obtained by The Washington Post... Sub. Req’d

340B Rebate Model Gets HRSA Endorsement; Pilot Program Limited To Medicare Negotiated Drugs

(7/31, Pink Sheet) ...HRSA announced a 340B rebate model pilot program involving the drugs subject to Medicare negotiated prices beginning in 2026. That apparently means Sanofi and Eli Lilly, which are among the more proactive companies promoting alternatives to 340B discounts, will not be eligible to participate in the pilot. Although limited at first, the number of drugs subject to the pilot could grow if HRSA believes the pilot is a success, the announcement says... Global Sub. Full

FDA Wants More Harmony Between CBER and CDER, Makary Tells Industry CEOs

(7/31, Max Bayer and Zachary Brennan, Endpoints News) ...FDA Commissioner Marty Makary told biotech and pharma CEOs that he wants to better align the agency's drug and biologics centers, just as one official was — at least temporarily — tapped to lead both. Makary said during Wednesday's "listening tour" stop in New York that he wanted the two centers to work more like a team and not as "fiefdoms," several attendees told Endpoints News on condition of anonymity to discuss the private event... Sub. Req’d

FDA Slaps Stronger Warnings On Opioids

(7/31, Nicole Lou, MedPage Today) ...The agency is requiring opioid manufacturers to add to the prescribing information that higher doses are associated with increased risk of serious harm, and that the risks of serious harms persist over the course of therapy, among other changes. Based on results of two postmarketing observational studies -- and the FDA advisory committee meeting discussing them this May -- new quantitative estimates of the risks of addiction, abuse, misuse, and fatal and non-fatal overdose in patients taking opioid analgesics long-term are also expected in labeling updates... Full

Upsher-Smith, Bora Host Iowa Gov. Reynolds to Discuss Supply Chain, Regional Collaboration

(7/31, Sandra Levy, Drug Store News) ...Upsher-Smith, a Midwest-based pharmaceutical company focused on specialty brands and generics, currently part of Bora Group, a global company specializing in pharmaceutical manufacturing, recently welcomed Iowa Governor Kim Reynolds to their Maple Grove, Minn., headquarters for a roundtable discussion and facility tour focused on advancing pharmaceutical innovation and exploring opportunities for regional collaboration... Full

Sun Pharmaceutical Says it Won't Expand US Manufacturing Base Amid Tariff Concerns

(8/1, Rica Bhattacharyya, The Economic Times) ...Sun Pharmaceutical, India's largest drug maker, is not planning to expand its manufacturing base in the US, citing sufficient existing capacity. The company remains watchful of potential reciprocal tariffs, though pharmaceuticals are currently exempt pending a US investigation... Full

Novo Nordisk Shares Extend Losses, Erasing Nearly All Gains Since Wegovy Launch

(8/1, Anna Pruchnicka, Elviira Luoma, Jacob Gronholt-Pedersen and Louise Breusch Rasmussen, Reuters) ...Shares in Novo Nordisk fell as much as 6% on Friday to their lowest since August 2021, extending recent losses to wipe out almost all the gains made since the drugmaker launched its blockbuster weight-loss treatment Wegovy. The fall comes after U.S. President Donald Trump on Thursday sent letters to 17 major pharmaceutical firms, including Novo Nordisk, telling them to cut drug prices in the United States. That prompted share price declines across the sector..."Trump doesn't have the mandate to tell Novo Nordisk how to price their products in the U.S., but investors are just panicking about the risk of another downgrade," said Nordnet analyst Per Hansen... Full

AbbVie Again Hikes Guidance as it Eyes Neuro, Obesity and PD-1xVEGF Deals

(7/31, Kyle LaHucik, Endpoints News) ...The company said Thursday that it had revenue of $15.4 billion in the second quarter, coming in $400 million more than analysts expected and up 6.6% from the $14.5 billion it reported in the same period a year ago...AbbVie has again upped its 2025 revenue guidance to $60.5 billion, according to remarks made by CEO Rob Michael on the company's earnings call. That's $800 million more than its most recent projection and $1.5 billion higher than the guidance given at the beginning of the year, he added. Michael and other executives also expressed interest in doing more deals in neuroscience, obesity and oncology, where it's keeping close tabs on the PD-1xVEGF competition... Sub. Req’d

India's GlaxoSmithKline Pharma Posts First Revenue Drop in Over Two Years

(8/1, Kashish Tandon, Reuters) ...The Indian unit of British drugmaker GSK Plc reported a 2% decline in its revenue from operations to 8.05 billion rupees ($92 million) for the first quarter ended June 30. GlaxoSmithKline Pharma said its performance during the quarter was "below anticipated levels," as it was hurt by "external factors such as seasonal disruptions"... Full

Bayer Says Pharma Sales Exceed Expectations, Bumps Full-Year Guidance

(8/1, Ayisha Sharma, Endpoints News) ...The German conglomerate revealed that its total Q2 sales reached €10.7 billion ($12.2 billion), although the number has yet to be confirmed by final audit. While it didn't parse out figures for each business, Bayer said Thursday that pharma sales were up 0.6% from the same quarter last year. In Q2 2024, its pharma business made €4.6 billion. The company added it expects full-year pharma sales to grow by zero to 3%, up from a prior forecast of a 1% to 4% decline... Sub. Req’d

Mallinckrodt, Endo Complete Merger to Create Global, Scaled, Diversified Therapeutics Leader

(8/1, Mallinckrodt Pharmaceuticals and Endo) ...The combined company is well-positioned to continue growing its brands portfolio across a wide range of therapeutic areas of significant unmet need, including endocrinology, gastroenterology, hepatology, neonatal respiratory critical care, nephrology, neurology, pulmonology, ophthalmology, orthopedics, rheumatology, and urology. In addition, the generics and sterile injectables business features a broad product portfolio, a leading controlled substances franchise, robust commercial and manufacturing infrastructure in the U.S. and internationally, extensive supply chain capabilities, and expertise in complex, highly regulated products... Full

Teva's ‘Support the Soul' Initiative Strengthens Israel's Therapists Post-October 7

(7/31, The Jerusalem Post) ...In the Jerusalem Post's special broadcast series "Healing Israel: A Nation in Trauma," Yarden Abarbanel, program lead of Teva Pharmaceutical's "Support the Soul" initiative, joined JPost Israel Daily News CEO Shanna Fuld to discuss the company's evolving mental health efforts after October 7. "Support the Soul was launched swiftly following October 7, aiming to do more during the challenging times Israel faces," Abarbanel explained, highlighting the program's emphasis on supporting trauma therapists nationwide. "Our focus is on the therapists, understanding they bear much of the emotional burden of Israeli society."... Full

'We've Run Different Scenarios': European Pharmas Insist They're Relaxed About EU Tariffs

(8/1, James Waldron, Fierce Pharma) ...The announcement of a 15% tariff on pharmaceutical imports to the U.S. from the EU may have not been the ideal backdrop for the busiest week of European pharma earnings this quarter, but CEOs appeared to be unfazed... Full

UK Approves Biogen's Qalsody After England Revises Reimbursement Approach

(7/31, Eliza Slawther, Pink Sheet) ...Biogen's Qalsody has been approved in the UK for patients with amyotrophic lateral sclerosis linked to SOD1 mutations. Biogen originally said it would not seek approval for Qalsody in the UK due to the assessment pathway that NICE, England's HTA body, had planned to use to make a reimbursement recommendation for the product. The company appears to have shifted strategies after NICE changed the assessment pathway to one that will allow for greater evidence uncertainties. Qalsody was authorized using the UK's International Recognition Procedure, a regulatory reliance pathway introduced after the country left the EU... Global Sub. Full

Switzerland Slammed With 39% Tariff Rate in US Trade Blitz

(7/31, Bastian Benrath-Wright, Hugo Miller and Jenny Leonard, Bloomberg Law) ...The outcome — detailed in an executive order Thursday — is higher than the 31% tariff rate Trump had threatened to levy in April and dashes hopes that the country would secure a more favorable deal. The Swiss government expressed its "great regret," pointing out that the new tariff rate differs "significantly" from a draft framework the countries had been negotiating...The Swiss economy rests on large contributions from industry giants Novartis AG and Roche Holding AG. Drugmakers face a double squeeze as Trump escalates his campaign to pressure them for lower prices, sending letters to 17 of the world's largest pharma companies demanding they charge the US what other countries pay for new medicines... Full

Greek Pharma Sector Braces for US Tariff Fallout, Patients Risk First Impact

(7/31, Vasiliki Angouridi, Euractiv) ...Greek pharmaceutical and medical technology executives have voiced growing concern over the anticipated extension of US tariffs to medicines and medtech products, warning that the move could severely disrupt innovation, fracture supply chains, and curtail patient access - particularly in smaller EU markets such as Greece... Full

Could U.S. Tariffs Drive Up Drug Prices? Manitoba Bioscience Group Says it's Complicated, But Possible

(8/1, Justin Fiacconi, CBC) ..."If a 200 per cent tariff were to be put into place then I think [pharmaceutical manufacturers] would have to potentially reconsider whether it makes sense to manufacture in Canada," says Shawn Bugden, dean of the school of pharmacy at Memorial University...As things stand, many pharmaceutical companies are waiting to see what will happen. CBC News has reached out to several pharmaceutical companies in Manitoba, but none have wanted to comment given the uncertainty of the situation they're facing. [Andrea Ladouceur, president of the Bioscience Association of Manitoba] says they're fearful that tariffs may force them to increase their prices. "At the end of the day, any increase in cost will be passed on to the consumer," says Ladouceur... Full

Indian Drugmakers Relieved But Wary as US Exempts Pharma Sector from New Trade Tariffs

(8/1, Sumi Sukanya Dutta, ThePrint) ...Pharma industry insiders believe that while the exemption has brought relief to the sector, the commentary coming from the US administration indicates that it could be temporary. "Indian medicines remain a cornerstone of the US-India relationship, as we play a crucial role in global and US healthcare by ensuring a steady supply of affordable drugs. The latest decision (to exempt drugs from reciprocal tariffs) like the April order underscores the critical role of cost-effective, life-saving generic medicines in public health, economic stability and national security," a senior executive with a leading drugmaker based on Mumbai told ThePrint... Full

Trump Tariffs To Push Up US Drug Prices, Won't Change India's Pharma Growth Playbook: Pharmexcil

(8/1, Shariq Khan, The Economic Times) ...The Pharmaceuticals Export Promotion Council of India (Pharmexcil) has warned that the US administration's decision to impose a 25% tariff along with additional penalties on all Indian imports starting August 1 will not only make things harder for Indian exporters but will also increase the cost of essential medicines in America, putting pressure on patients and healthcare systems... Full

Indian Govt Eyes Minimum Import Price to Shield Pharma from Cheap Chinese Imports

(7/31, The Pharma Letter) ...As Indian drug manufacturers cry foul over the surge of cheap Chinese pharmaceutical raw material imports, the Indian government is actively considering the imposition of a minimum import price (MIP) on specific pharmaceutical raw materials. The move could cover approximately 41 crucial pharmaceutical raw materials, including drug intermediates and active pharmaceutical ingredients (APIs) used in antibiotics and anti-cholesterol therapies, primarily imported from China... Sub. Req’d

Indian Pharma Braces for Trump Tariff Fallout

(7/31, Naini Thaker, Forbes India) ...According to Vishal Manchanda, equity research analyst- pharma, Systematix Group, the Indian generic drug manufacturers will likely have no choice but to pass on the additional tariff costs to US consumers. "For basic, commodity drugs, the pricing is already so competitive that absorbing the cost internally isn't feasible. At the same time, the US may also have limited alternatives, as no other country can match India's scale and pricing efficiency in supplying low-cost generics," he explains... Full

Ignoring China's Biotech Industry is No Longer An Option. It's a Recipe for Disaster

(7/31, John Carroll, Endpoints News) ...There's a lot less doubt and a lot more fear and respect driving research into China's biotech circles these days. Getting a detailed understanding of what's to come is essential to defining biotech risk and opportunity in the industry. And covering China biotech in-depth, from the ground up, is no longer an option. It's mandatory... Sub. Req’d

Mexico Speeds Up Market Access With Regulatory Reliance Guidelines

(7/31, Francesca Bruce, Pink Sheet) ..."Regulatory reliance helps simplify, update and clarify Mexico's regulatory framework and increases efficiency," according to the medicines regulator, COFEPRIS. It added that the guidelines would ensure wider, faster and safer access to high quality medicines and medical devices. The guidelines were published on July 18 in the Diario Oficial de la Federación (the Official Journal). They apply to medicines, including new chemical entities, generics, innovative biotechnology products, biosimilars and vaccines. They also apply to medical devices... Global Sub. Full

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