Monday, November 25, 2024

Pfizer Led Industry Wide Sales Surge in Q3 After Several Quarters of Dominance by Eli Lilly, Novo Nordisk

(11/25, Kevin Dunleavy, Fierce Pharma) ...With a 32% increase in sales, Pfizer delivered the No. 1 bump among large drugmakers in the period, topping the sales growth figures for Novo (21%) and reigning champion Lilly (20%)...Other top-20 companies that pulled off double-digit sales increases in the third quarter were Amgen (23%), AstraZeneca (18%) Takeda (13%), Sanofi (12%), Teva (12%) and Regeneron (11%)...Teva's hefty increase was propelled by the success of the company's generic and biosimilar medicines, especially in the U.S. where sales of the products were up 30% YOY... Full

Amneal Set To Debut US Byetta Competition – Two Decades After Market Entry

(11/25, Dean Rudge, Generics Bulletin) ...Amneal's approval marks one of the first generic GLP-1 injectables to be approved in the US. Earlier this year, Teva launched an authorized generic of another in the US, Victoza (liraglutide) to treat type 2 diabetes, under the terms of its patent settlement with originator Novo Nordisk...Almost a decade ago, Teva had brokered a patent-litigation settlement with AstraZeneca providing it with the green light to market a generic version of Byetta beginning in October 2017. However, more than seven years on, an approval or launch has not been forthcoming. Indeed, Teva appears to have dropped any plans to enter the market, having not mentioned its exenatide opportunity for several years; and sparsely before that... Global Sub. Full

Thousands of Children Affected by ADHD Medication Shortage

(11/24, Eleanor Hayward, The Times) ...There has been a national shortage of ADHD medications for more than a year, with the worst affected drug currently methylphenidate, which is commonly used for children and sold under the brand names Concerta and Ritalin. Two thirds of parents said they faced problems getting their child's medication at the beginning of this school year, according to a survey by the charity ADHD UK, with some saying their children are unable to concentrate in lessons or having to take days off... Full

Exclusive: Thousands Turn to Wegovy Copies Each Month as FDA Considers Shortage Status

(11/25, Patrick Wingrove, Reuters) ...More than 200,000 prescriptions for copies of Novo Nordisk's weight-loss drug Wegovy are getting filled by U.S. patients each month, an industry group told the U.S. drugs regulator in a letter, saying it should consider their role in alleviating the obesity drug supply crunch before barring them... Full

Aurobindo Pharma Partners with Global Pharma Major for Respiratory Product Development

(11/25, Farhat Nasim, Press Trust Of India) ...Aurobindo Pharma USA Inc has entered into a collaboration and license agreement with a global pharma major for development and commercialisation of products, the Hyderabad-based drug firm said in a regulatory filing. The partnership is for an initial estimated development duration of three-five years, it added... Full

Novo Holdings Set to Win EU Nod for $16.5 Bln Catalent Deal, Source Says

(11/22, Yun Chee Foo, Maggie Fick, Reuters) ...Novo Holdings is set to gain unconditional EU antitrust approval for its planned $16.5 billion takeover of U.S. contract drug maker Catalent, a person with direct knowledge of the matter said on Friday, clearing a key hurdle. Another source said Catalent is preparing senior management for the deal to go through... Full

UK Watchdog Fines Viatris $1.9 Mln Over Rule Breach in Theramex Probe

(11/22, DhanushVignesh Babu, Reuters) ...Britain's competition watchdog fined U.S. firm Viatris 1.5 million pounds ($1.88 million) on Friday for violating an order during its probe into pharma company Theramex's acquisition of European rights to two Viatris product ranges... Full

Drug or Biologic? An Eli Lilly Lawsuit Could Impact Weight Loss Drug Compounders

(11/22, Nicole DeFeudis, Endpoints News) ...Eli Lilly and Novo Nordisk have filed dozens of lawsuits against compounding pharmacies marketing their own versions of popular weight loss and diabetes drugs. A new legal strategy could put Lilly one step ahead of compounders, if it's successful. The case may come down to one amino acid... Full

Alembic Pharma Gujarat Facility Gets 5 Observations from USFDA

(11/25, Business Standard) ...The GMP inspection was conducted from November 14, 2024 to November 22, 2024. The USFDA issued Form-483 with 5 observations. The company stated that it would provide a comprehensive response to the USFDA for the observations within the stipulated period. It also committed to maintaining the highest quality standards and compliance at all times... Full

McKinsey Calls Endo Trustee's Opioid Advice Suit Blame Shifting

(11/22, Alex Wolf, Bloomberg Law) ...A bankruptcy trust working to raise funds for Endo creditors is trying to attack and hold McKinsey responsible for the same acts that the trust has already accused the drug maker's own executives of committing, the global consulting firm said in a filing Thursday to the US Bankruptcy Court for the Southern District of New York. Taking exception to accusations that McKinsey should pay for helping Endo boost sales of addictive painkiller Opana ER, the firm said the complaint was "replete with admissions of misconduct by the debtors' directors and officers," who the general unsecured creditor trust is actively litigating against... Sub. Req’d

Popular Asthma Drug Singulair Could Be Linked to Mental Health Side Effects, Suicides: FDA

(11/24, Julia Gomez, USA Today) ...The Food and Drug Administration presented the preliminary results of a study on the asthma drug Singulair, which is sold generically as montelukast, to a "limited audience" at the American College of Toxicology meeting in Austin, Texas on Nov. 20, according to Reuters, which reviewed the scientific presentation. Lab tests showed "significant binding" of the drug to multiple brain receptors, according to Jessica Oliphant, a deputy director at FDA's National Center for Toxicological Research... Full

Novel Relapsed/Refractory CLL Therapies Have Similar Safety Profiles

(11/23, Jared Kaltwasser, AJMC) ...Novel targeted therapies for R/R CLL, including venetoclax plus rituximab, acalabrutinib, and zanubrutinib, have favorable safety profiles. Bendamustine plus rituximab showed a lower risk of severe adverse events compared to other therapies in the analysis. Zanubrutinib had higher risks of hypertension and bleeding but, along with acalabrutinib, showed superior cardiac safety over first-generation BTK inhibitors. Further research is needed to comprehensively assess the long-term safety profiles of these therapies... Full

How Early Adopters Are Shaping the Future of Biosimilars

(11/24, Skylar Jeremias, Center For Biosimilars) ...Early adopters have played a key role in advancing biosimilar acceptance by sharing real-world data on their successful programs. Sophia Humphreys, PharmD, MHA, BCBBS, director of system formulary management at Sutter Health, a market access strategist and biosimilar expert, emphasizes how these organizations have implemented effective strategies such as pharmacoeconomic analyses and leveraging implementation tools, providing valuable guidance for smaller or rural hospitals with fewer resources. She notes that these pioneers carry much of the initial resistance, making it easier for others to follow... Full

Big Pharma is Pretty Great, Actually

(11/22, David Harsanyi, Washington Examiner) ...There's probably no industry more reviled in the age of populism than Big Pharma. Both political parties now engage in knee-jerk demonization of one of the most successful and valuable sectors of the economy. It's not just lazy and irrational — it's probably going to get people killed. No industry has done as much to improve our lives as Big Pharma, save perhaps Big Ag, which efficiently feeds billions of humans, many of whom, until very recently, were constantly on the brink of starvation... Full

‘We Dodged a Bullet': Biotech and Pharma React to Selection of Marty Makary for FDA Commissioner

(11/23, Allison DeAngelis, Adam Feuerstein, Matthew Herper, Lizzy Lawrence, Nicholas St. Fleur, and Jonathan Wosen, STAT Plus) ...STAT reporters reached out to key figures in biotech, pharma, and medical devices to find out what they think about President-elect Trump's pick of Johns Hopkins pancreatic surgeon Martin "Marty" Makary as commissioner of the Food and Drug Administration. Makary, like Trump's intended Health and Human Services selection, Robert F. Kennedy Jr., is part of the "Make America Healthy Again" movement, focused on addressing chronic disease. He was also a critic of some Covid-19 pandemic measure, including vaccine mandates... Sub. Req’d

FDA Pick Makary's Conventional Background Could Clash With Some Of RFK Jr.'s Views

(11/22, Jessica Karins, InsideHealthPolicy) ...Surgeon and author Marty Makary, President-elect Donald Trump's choice to head FDA, has a more conventional background than Trump's picks for the top roles at HHS and CMS, which could set him up him to clash with "Make American Healthy Again" priorities on some topics while sharing common ground on others, including his desire to reverse course on FDA's current endorsement of universal and regular COVID-19 vaccination... Sub. Req’d

Prognosis: Under Trump, The CDC is in Big Trouble, But The FDA Might Be OK

(11/23, Matthew Herper, STAT Plus) ...Many investors in biotechnology and pharma stocks want to believe Makary represents a return to normal or will even usher in a new era where the FDA will still require strong medical evidence but will be less onerous toward companies that are trying to innovate. They should stay cautious. Technically, the HHS secretary has the ability to overrule the FDA commissioner on many decisions. And there may be moments where Makary has to make tough choices about what political higher-ups want and what is right for medicine. Right now, it's not yet clear how he will decide when those moments arrive... Sub. Req’d

Marks Believes Trump Team Will Not Threaten US FDA's Medicines Expertise

(11/22, Andrew McConaghie, Pink Sheet) ...CBER Director Peter Marks told a Jeffries conference in London that the FDA's high standards would be preserved during the second Trump Administration. Marks also said that he would stay at the agency "as long as I'm considered to be welcome." But he conceded that CBER may be able to reduce some cell and gene therapy regulation... Global Sub. Full

Trump's Tariffs Could Raise the Cost of Generic Drugs in the U.S.

(11/22, Berkeley Lovelace Jr. and Sara G. Miller, NBC News) ...Dr. Aaron Kesselheim, a professor of medicine at Harvard Medical School, said that about half of all generic drugs are manufactured overseas and that about 80% of all active pharmaceutical ingredients, or APIs, are produced abroad, in China, India and other places...If Trump doesn't grant some kind of exemption, importing generic drugs is likely to become more expensive — a cost that could be passed on to patients or force more struggling generic drugmakers out of the U.S., said Dr. Janet Woodcock, a former acting commissioner of the Food and Drug Administration... Full

Dems Call For Final March-In Rights Framework Before Trump Takes Over

(11/22, Gabrielle Wanneh, InsideHealthPolicy) ...Democratic lawmakers are pressing the Biden administration to finalize a framework floated last year that would allow the government to use its rarely invoked march-in authority as a tool to lower the cost of expensive prescription drugs developed using U.S. taxpayer funding. President-elect Donald Trump issued an 11th-hour proposal before leaving his first term that prohibited use of march-in rights to license third parties to manufacture more affordable versions of drugs developed with federal funding... Sub. Req’d

Sanofi Plans to Change Hospital Drug-Discount Program

(11/22, Jared S. Hopkins, The Wall Street Journal) ...The pharmaceutical company plans to change its policy on how it gives discounts to certain hospitals. Sanofi will require institutions to provide pharmacy and medical claims information before receiving federally mandated discounts. The company sent a letter, which was viewed by The Wall Street Journal, to hospitals outlining its new model on Friday, according to people familiar with the matter... Sub. Req’d

Addressing Patent Hurdles, Payer Barriers, and Interchangeability

(11/22, Cameron Santoro, AJMC) ...Global Biosimilars Week, a worldwide online biosimilar advocacy event hosted by the International Generics and Biosimilars Association, took place between November 11 to November 15.1 The event focused on challenges that exist among the patent system, payers and pharmacy benefit managers, and interchangeability designation while solutions were proposed to improve biosimilar adoption... Full

Europe Fights Back Against Antimicrobial Resistance

(11/25, The Pharma Letter) ...Developing new antimicrobials is critical to tackling AMR, but the drug development pipeline remains sluggish. The World Health Organization has identified just 32 antibiotics in clinical development targeting priority pathogens. In response, the European Union is introducing a transferable exclusivity voucher (TEV) system, as part of a broader revision of pharmaceutical legislation. Under this plan, companies developing a priority antimicrobial could gain an additional 12 months of exclusivity for another product, a move designed to incentivize innovation by guaranteeing predictable returns... Sub. Req’d

Exploring Drug Shortages in European Markets: The Causes, Analysis, and Response

(11/25, Alex Watt, Pharmaceutical Technology) ...GlobalData reviews the current drug shortage landscape across several European markets (Austria, Belgium, Italy, Norway, Slovenia, Spain, and Portugal) while looking at key trends for these shortages such as geographic distribution, generic and reimbursement status, and multi-brand impact. Acknowledgement will also be given to various government responses to alleviating these drug shortages. Of the assessed markets, Norway reports the greatest number of packs currently out of stock... Full

EU Regulators Eye Social Media For Real-World Data Insights

(11/22, Vibha Sharma, Pink Sheet) ...Ongoing efforts in the EU to expand the availability of real-world data sources for regulators have resulted in a growing focus on data from social media platforms. It has prompted EU Big Data Steering Group (BDSG) to recommend a range of actions, including launching proof-of-concept studies, to help evaluate if social media data can generate real-world evidence for regulatory decision-making... Global Sub. Full

MFI Celebrates Generics And Biosimilars On Ireland's General Election Manifestos

(11.22, Urte Fultinaviciute, Generics Bulletin) ...Medicines for Ireland had its demands for the off-patent sector heard by some political parties, which are pledging to improve access to generic and biosimilar drugs ahead of the election..."We are encouraged to see our calls reflected in political manifestos, demonstrating a clear commitment to improving the accessibility and sustainability of generic and biosimilar medicines," MFI chair Paul Neill commented on these pledges... Global Sub. Full

India Seeks to Set Global Pharma Standards with its Bharat FDA

(11/25, The Pharma Letter) ...Aiming to reshape its image and redefine the landscape, India is determined to carve out its own identity in the global pharmaceutical sector. Finance Minister Sitharaman is championing the creation of a Bharat Food and Drug Administration to establish international standards for pharmaceutical products. The proposed regulatory framework aims to set global pharmaceutical standards, streamline processes, reduce bureaucratic hurdles, ensure a more robust regulatory framework, foster innovation within the industry, and position India as a leader in science and technology... Sub. Req’d

India's Pharma Sector Registers Strong Q2 FY25 Growth, Driven by North America Market: Report

(11/25, ANI) ...Major pharmaceutical companies of the country reported a 10 per cent year-on-year (YoY) growth in the second quarter of FY25, largely driven by strong performance in North America and the domestic market, according to a report by Axis Securities...The report also outlined a positive outlook for the pharmaceutical sector over the next three years, with a healthy pipeline expected in biosimilars, GLP-1, and peptides. Biosimilars, GLP-1, and peptides are related to the treatment of diabetes and other conditions. Companies with a significant share of chronic portfolios continue to outperform the overall market... Full

Dr Reddy's, Aurobindo Pharma, Others Ink Pact with Telangana Govt to Set Up Facilities in Pharma City

(11/22, Press Trust Of India) ...Six prominent pharmaceutical companies, including Dr Reddy's Laboratories, Aurobindo Pharma, and Hetero Labs, have signed memorandums of understanding (MoUs) with the Telangana government to set up facilities in the Pharma City near here, the government announced on Friday. The companies have committed to invest over Rs 5,260 crore, which is expected to create 12,490 job opportunities in the pharma sector, according to an official release... Full

Japan Prices Kisunla Above Leqembi But May Cut In Future

(11/25, Lisa Takagi, Pink Sheet) ...Eli Lilly will launch its Alzheimer's disease therapeutic Kinsula (donanemab) in Japan on November 26, after receiving a national health insurance price. The reimbursement price has been set at JPY66,948 per 350mg/20ml vial, equating to a JPY8,560 daily treatment cost for a 50kg patient. Japan's regulatory authorities have suggested that further pricing reviews may take place, considering the impact on the country's rapidly aging society... Global Sub. Full

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