Thursday, November 14, 2024

UK's NHS Bets Big On Teva's Champix Generic

(11/13, David Wallace, Generics Bulletin) ...Teva's generic version of Pfizer's Champix (varenicline) daily smoking-cessation tablet is to be rolled out to "tens of thousands" of smokers in England, the country's National Health Service has announced, as part of efforts to help them quit... Global Sub. Full

Hair Loss Products Full Steam Ahead

(11/14, Zhou Wenting, China Daily) ...Regro, a medicine for external use for people troubled by hair loss, made its China debut at the booth of biopharmaceutical company Teva...Linda Pang, head of commercial at Teva Greater China, said that Regro is a leading brand in this field and a word-of-mouth product that has been proven in some markets overseas, including Europe and the United States. "The product is expected to be available to Chinese consumers on cross-border e-commerce platforms soon," said Pang... Full

Viatris Names A Trio Of Complex Injectable Targets Amid Teva Symbicort Interest

(11/13, Dean Rudge, Generics Bulletin) ...Back in May, Viatris had projected that generic Venofer and glucagon would be launched by the company in the second half of 2024. Meanwhile, Mistras revealed that Viatris had a meeting with the US Food and Drug Administration planned for December 2024 for the company's proposed once-monthly glatiramer acetate ‘GA Depot' product – a follow-on to Teva's Copaxone treatment for relapsing forms of multiple sclerosis, developed in partnership with Mapi Pharma...Another complex generic on the slate is a version of Novartis' Sandostatin LAR Depot (octreotide acetate) for injectable suspension. Last month, Teva leapfrogged Viatris, launching the first-and-only US generic version of the synthetic polypeptide indicated to treat acromegaly and severe diarrhoea for carcinoid syndrome... Global Sub. Full

BMS, Merck, Amgen and More Must Look to M&A to Offset Looming Patent Lapses: Leerink

(11/13, Fraiser Kansteiner, Fierce Pharma) ...In the coming years, Bristol Myers Squibb, Merck, Amgen, Novartis and AstraZeneca are staring down the greatest level of exposure to generic and biosimilar competition while Vertex, Gilead Sciences, Sanofi, Novo Nordisk and Eli Lilly are the least exposed over the 2025-2030 timeframe, Leerink said... Full

Sandoz, Amneal Get Mixed Ruling in State Drug Price-Fixing Case

(11/13, Katie Arcieri, Bloomberg Law) ...Sandoz Inc., Pfizer Inc., and Amneal Pharmaceuticals Inc. are among a group of generic-drug manufacturers that will face some price-fixing claims brought by more than 40 states and US territories after a federal judge allowed them to move forward while dismissing others... Sub. Req’d

Otsuka and ICU Medical Forge IV Manufacturing Network to Supply the US

(11/13, Anna Brown, Endpoints News) ...The joint venture will have a combined capacity of 17 global manufacturing sites to provide roughly 1.4 billion units of IV drug products to the US market each year. It is expected to start from the second quarter of 2025, according to a Tuesday release. The two companies will also develop new IV drug products that ICU said have been historically hard to fund. ICU will promote any new drugs formed from the venture... Full

Cipla Gets Eight Observations After FDA Inspection at Bengaluru Plant

(11/13, CNBC TV-18) ...The inspection, which took place from November 7 to November 13, concluded with the issuance of Form 483, a document outlining conditions the regulator believes may need improvement for compliance with manufacturing practices... Full

Dr Reddy's Gets 27 Lakh Penalty from Mexican Drug Regulator

(11/14, Press Trust Of India) ...The drug regulatory body of Mexico has imposed a penalty of 27 lakh on the company for deviation from prescribed guidelines in filing intimation of import of a reference standard for one of the APIs, the Hyderabad-based firm said in a regulatory filing. Additionally, the fine was imposed due to an error in the date of the invoice and also in the name of the reference standard versus import license, it added... Full

Biosimilars Are Getting a Foothold and Becoming Preferred, Says Dr James Chambers

(11/13, Laura Joszt, MA, AJMC) ...Early in a biosimilar's life cycle, it can be challenging to gain a foothold, but over time biosimilars are gaining traction and becoming preferred products, said James D. Chambers, PhD, professor, Center for the Evaluation of Value and Risk in Health, Institute for Clinical Research and Health Policy Studies, Tufts Medical Center... Full

Health System Pharmacy Rises to the Challenge During National Pharmacy Week to Manage the National Sterile Fluid Shortage

(11/13, Curtis E. Haas, PharmD, FCCP, Pharmacy Times) ...Pharmacy Week is always a great time each year to reflect on and celebrate all the great things that health system pharmacists, pharmacy technicians, and support staff accomplish every week of the year, but this year it has been particularly evident to me because we had to contribute in so many ways to the management of this fluid crisis. Managing shortages of drugs has become so second nature in pharmacy over the past decade that we do it as part of our daily routine without an awful lot of fanfare. What was once crisis-like and newsworthy is now mundane and rarely even warrants communication outside the pharmacy beyond an embedded message in the electronic medical record... Full

U.S. Drug Overdose Deaths On Pace to Fall Below 100,000 This Year

(11/13, Lev Facher, STAT) ...Reported drug deaths fell nearly 17% during the 12-month period ending in June, to 93,087, according to new statistics released this week by the Centers for Disease Control and Prevention...While drug overdose deaths have been trending downward for months, some researchers and public health officials have cautioned that the decrease may represent a mere data blip, not a genuine shift in the nation's public-health fortunes. But during a panel discussion on Wednesday, CDC Director Mandy Cohen cast the latest decrease as a sign that the country's overdose-prevention efforts are working... Full

Opioid Overdose Deaths Drop for 12th Straight Month, Now Lowest Since 2020

(11/13, Alexander Tin, CBS News) ...Almost all states, except for a handful in the West from Alaska through Nevada, are now seeing a significant decrease in overdose death rates. Early data from Canada also suggests overdose deaths there might now be slowing off of a peak in 2023 too... Full

Senate Judiciary To Mark Up Patent Bills, Weighs AI Issues

(11/13, InsideHealthPolicy) ...The full Senate Judiciary Committee on Thursday will hold a business meeting to consider multiple nominations and a handful of bills, including two pieces of bipartisan legislation related to pharmaceutical, diagnostic and AI patents... Sub. Req’d

With GOP Control of Congress, Trump Has Broad Power to Reshape Health Care

(11/13, John Wilkerson, STAT Plus) ...The GOP is set to have at least 218 seats in the House of Representatives, maintaining control of the chamber, according to CNN, NBC, and ABC. The party has at least 52 seats in the Senate. Major health care issues are potentially at stake, including subsidies for Affordable Care Act plans, Medicaid funding, restructuring of massive federal agencies like the FDA and CDC, access to telehealth, how Medicare pays doctors, drug middlemen reforms, drug price negotiations, and China's rise in biotechnology... Sub. Req’d

Republican Sweep Creates Smoother Path For Biopharma Policy Priorities

(11/13, Cathy Kelly, Pink Sheet) ...With the Republicans gaining control of the House of Representatives on November 13,, along with the Senate and White House following the November 5, elections, the new majority could help biopharma achieve key legislative priorities, such as 340B outpatient drug discount program reform as well as revision or even repeal of the drug pricing provisions in the Inflation Reduction Act... Global Sub. Full

AMA Furthers Policy to Address Nation's Growing Drug Supply Shortages

(11/13, AMA) ...The AMA's new policy supports efforts to encourage federal review and oversight of the practice by compounding pharmacies to advertise drugs that are actively in shortage, combat artificial drug shortages, and offer incentives to manufacturers seeking to invest in manufacturing processes... Full

Medicare Part D in 2025: Preferred Pharmacy Networks Fade in a Collapsing PDP Market

(11/13, Adam J. Fein, Ph.D., Drug Channels) ...The destruction of the Part D market marks yet another unintended consequence of the Inflation Reduction Act of 2022 (IRA). The IRA makes PDPs less economically viable and will drive even more seniors into Medicare Advantage Prescription Drug (MA-PD) plans—despite the challenges facing those plans. The 2025 decline will occur even after CMS gifted $7 billion to PDPs to prevent a complete collapse of the 2025 market... Full

Trump's Planned Ramaswamy-Musk Commission Stokes Fears Of Major FDA Cuts

(11/13, Jessica Karins, InsideHealthPolicy) ...President-elect Donald Trump has announced that biotechnology executive and FDA critic Vivek Ramaswamy, along with controversial businessman Elon Musk, will head a new commission to slash federal regulations and slim down federal government spending, raising further concerns about potential rollbacks of rules and major staff cuts at FDA and other health agencies... Sub. Req’d

Three Ways Trump Could Disrupt The US FDA

(11/13, Michael McCaughan, Pink Sheet) ...The FDA could be significantly changed by Donald Trump's stated efforts to remake the federal government. A disruptive leader could be appointed that alters FDA decision-making processes or career staff could be forced out as part of a "purge." Even if the agency is spared from major changes, staff departures and hiring difficulties could impact performance... Global Sub. Full

US FDA Heading In ‘The Same Direction' As EMA On AI In Drug Development

(11/13, Eliza Slawther, Pink Sheet) ...The US Food and Drug Administration was "thrilled" when the European medicines regulatory network –comprising the European Medicines Agency, the European Commission and national competent authorities – released its multi-annual workplan, because it showed "alignment in where the FDA and EMA were going," according to Tala Fakhouri, associate director for data science and AI policy at the FDA... Global Sub. Full

Drug Inspector Attrition Leads to 'Many Fewer' Checks Than 2016 Peak, GAO Says

(11/13, Zachary Brennan, Endpoints News) ...The US Government Accountability Office published a new report detailing concerns with the staffing of the FDA's drug inspection program, and the fact that the agency continues to conduct "many fewer inspections" than at its peak in 2016. After only partially bouncing back from a pharma manufacturing site inspection backlog caused by the Covid-19 pandemic, the GAO said the agency in 2023 still conducted 36% fewer inspections than in 2019. And FDA drug investigator vacancies grew from 25 (out of about 250 total inspectors) in November 2021 to 73 vacancies in 2023, according to the report... Full

FDA is Still Struggling with a Lack of Inspectors, But Doesn't Have a Plan, Watchdog Finds

(11/13, Ed Silverman, STAT Plus) ...Between November 2021 and this past June, the vacancy rate among investigators increased to 16% from 9%. Meanwhile, the FDA conducted 621 foreign and 444 domestic inspections in fiscal year 2023, down 36% from fiscal year 2019. The drop was attributed, in part, to the lack of investigators and a less experienced staff, according to a report by the U.S. Government Accountability Office... Sub. Req’d

Protecting Innovation in Europe

(11/13, Stephanie Vine, The Medicine Maker) ...A revamp of the EU's pharma legislation has raised alarm bells in the industry. The legislation was developed to improve security of supply, support innovation, and improve access to reasonably priced medicines, but some stakeholders believe it could have the opposite effect, particularly when it comes to attracting more pharmaceutical investment to the region and getting more innovative medicines to Europeans. We speak with Claus Zieler, Chief Commercial Officer at Astellas and a member of the board of EFPIA, to learn more about Europe's access to medicine problem... Full

UK Regulator Wants More Patient Input At Pre-Authorization Stage

(11/13, Ian Schofield, Pink Sheet) ...The UK medicines agency, the MHRA, says it is planning to increase the role of patients in its scientific assessments by boosting their input at the pre-authorization stage, possibly in cases such as the submission of a new active substance, a new indication of an existing drug, or a combination product... Global Sub. Full

Bulgarian Pharma Market Gained Post-Pandemic Boost, According to New Analysis

(11/13, Antonia Kotseva and Krassen Nikolov, Euractiv) ...Bulgaria's pharmaceuticals market experienced significant growth in 2023, with sales increasing 14.7% to €2.7 billion and oncology therapies leading in the hospital drug sales category. The aftermath of the COVID-19 pandemic seems to be leading the growth, with lessons learned nudging Bulgarian's better attitude towards their health... Full

Navigating New Risks: How China's Anti-Espionage Law Could Impact Pharmaceutical Supply Chains

(11/13, Olivier Lantrès and Myriam Danziger, PharmaPhorum) ...The pharmaceutical industry is facing another challenge as China seems to strengthen its Anti-Espionage Law, which introduces uncertainties that could disrupt the global supply of essential drug ingredients. With drug shortages already a significant concern, this development adds further pressure on the industry to navigate a rapidly changing landscape and secure its supply chains... Full

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