Tuesday, September 10, 2024

Generic Drug Sponsors May Discuss Alternative BE Approaches During Pre-ANDA Meetings

(9/9, Kate Rawson, Pink Sheet) ...Teva requested the change to the draft guidance, arguing that otherwise the meetings would be "completely one-sided conversations."...The communication plan outlined in the draft "is unnecessarily restrictive, not useful, and inconsistent with the process agreed to during the GDUFA III negotiations," Teva wrote. The company added that the GDUFA III goals letter stipulates a 60-minute teleconference to allow "a generous amount of time intended to permit robust, back-and-forth discussion between FDA and ANDA sponsors on bioequivalence and other pre-approval testing issues."... Global Sub. Full

Teva Case for Multiple Expansion 'Remains Solid,' Says Jefferies

(9/9, The Fly) ...Jefferies notes that better performance in Teva's core businesses has driven the "exceptional (and warranted)" 73% move up in shares year-to-date and while the firm continue to like the setup in the second half, it acknowledges that Teva will "need the pipeline to carry the baton for a bit."... Full

Teva Resolves Baltimore's Opioid Litigation with $80M Settlement

(9/9, Zoey Becker, Fierce Pharma) ...After opting out of Teva's $4.25 billion national opioid settlement last year, the city of Baltimore has secured its own payout through a settlement deal worth $80 million. Teva will make an initial payment of $35 million by the end of the year and hand over the rest by July 1, 2025, Baltimore's mayor Brandon Scott said in a Monday press release... Full

Baltimore Wins Another $80 Million in Opioid Settlement Money

(9/9, Madeleine O'Neill, The Baltimore Sun) ...The city opted out of previous global settlements with Teva and other major opioid companies to pursue its own lawsuit in hopes of winning larger payouts. The settlement announced Monday is more than seven times what Baltimore would have received as part of a national settlement with Teva, the city said in a news release. Teva also will pay out the full $80 million by July 2025... Sub. Req’d

Baltimore Gets $80M in Latest Win Against Opioid Manufacturers

(9/9, Lee O. Sanderlin, The Baltimore Banner) ...Of the $80 million to be paid by Teva, $5 million will go to "education and outreach efforts" about the 988 system, a hotline for people experiencing crisis or considering suicide. Another $3 million will go to the treatment facility Penn North Recovery Center and $2 million to BMore Power, a harm reduction group... Full

Cheap Teva Shock Should Reward Patients Investors

(9/9, Larry Ramer, Seeking Alpha) ...Teva is poised to benefit from rising demand for generic drugs due to a favorable macro and political environment...Teva's generic drug revenue surged 16% in Q2, and the unit's continued growth is expected to significantly boost the firm's overall revenue. Governments and consumers are increasingly opting for cost-effective generic drugs. The latter trend is likely to help boost demand for Teva's generic products... Full

Cigna Adopts $0 Stelara Biosimilar Program More Rapidly Than For Humira

(9/10, David Wallace, Generics Bulletin) ...Cigna's Evernorth has announced a program that will see the PBM offer in the US an unidentified ustekinumab biosimilar at $0 out of pocket for its Accredo patients from early next year...Even outside of its $0 out-of-pocket scheme for adalimumab biosimilars, Cigna has been active in recent months in striking partnerships with suppliers that could potentially open up the market significantly for Humira rivals, including alliances with Boehringer Ingelheim as well as US market partners Teva and Alvotech... Global Sub. Full

Sandoz Is Covering ‘Six Of Eight' GLP-1 Opportunities, With Plans To Evolve

(9/10, Dean Rudge, Generics Bulletin) ...Speaking during the firm's recent Sandoz Strategic Review 2024 event in Zurich, Switzerland, Sandoz's management underlined plans in the midterm to use a partnered approach to spring up early in developed non-US, non-EU markets like Canada and Brazil, targeting significant opportunities such as semaglutide. Using this approach, the firm will look to "gather insights on the complexity, the regulatory frameworks and the commercial landscape as we prepare for some of the bigger markets in the next decade," according to Sandoz's CEO, Richard Saynor... Global Sub. Full

Apotex Secures Two Firsts With US Sprycel And Oxtellar ER Rivals

(9/9, Adam Zamecnik, Generics Bulletin) ...Apotex Corp has secured two firsts in the industry as it launched two generic drugs in the US, leading with a version of the leukemia drug Sprycel (dasatinib)...According to the FDA's database of approved drugs, Teva, Dr Reddy's, Lupin, Alembic and Biocon currently hold tentatively-approved Sprycel abbreviated new drug application products... Global Sub. Full

Lupin Launches Higher Mirabegron Dose ‘At-Risk'

(9/10, Urte Fultinaviciute, Generics Bulletin) ...Lupin and Zydus have established a two-player market for their generic versions of mirabegron, while patent litigation with originator Astellas continues on. Despite the ongoing litigation with originator Astellas, Lupin decided not to wait around and launch its 50mg generic rival to Myrbetriq (mirabegron)...Lupin joins another generics giant Zydus, which also has mirabegron tablets on the US market. Both firms announced the launch of their 25mg doses in April after a US district court recommended against granting injunctive relief to Astellas... Global Sub. Full

Hikma Launches Multiple Concentrations Of Clindamycin In The US

(9/9, Adam Zamecnik, Generics Bulletin) ...Hikma Pharmaceuticals has launched its injectable antibacterial treatment clindamycin in 5% dextrose injections in multiple concentrations in the US, further boosting the company's presence as a key player in the generic drug industry. The generics manufacturer specifically launched the product in three concentrations, starting with 300mg/50ml vials and continuing with 600mg/ml and 900mg/50ml concentrations... Global Sub. Full

Hikma Pharmaceuticals Completes Acquisition of Xellia's FDF Business

(9/10, Alliance News) ...Hikma Pharmaceuticals PLC announced on Tuesday it has completed its acquisition of the US finished dosage form business. Denmark-based Xellia Pharmaceuticals ApS...Hikma's transaction is expected to support the long term grown of its Injectables business, as well as diversify and enrich its US Injectables portfolio and pipeline. It will also expand Hikma's manufacturing capacity and enhance its research & development capabilities... Full

AAM Warns Hikma Case Risks Narrowing Skinny-Label Path To ‘Vanishing Point'

(9/9, David Wallace, Generics Bulletin) ...In an amicus brief filed in support of Hikma over its US skinny-label generic dispute with Amarin, local industry association the AAM warned that the indication carve-out process that "began as a shield" has now "become a sword that is being wielded against the very generics the law was intended to protect."... Global Sub. Full

AstraZeneca Says Lung Cancer Drug Trial Shows No Significant Improvement in Overall Survival

(9/9, Maggie Fick, Reuters) ...Detailed results from one of AstraZeneca's key lung cancer trials released on Monday showed that its experimental precision drug did not significantly improve overall survival results for patients in the trial. The overall survival, or OS rates, in the TROPION-Lung01 trial "did not reach statistical significance", the company said in a presentation at the World Conference on Lung Cancer in San Diego... Full

GSK's Long-Acting Asthma Drug Halved Attacks in Phase 3, Backing Up Blockbuster Hopes

(9/9, James Waldron, Fierce Biotech) ...GSK's long-acting asthma treatment has been shown to halve the number of attacks in a pair of phase 3 trials, supporting the Big Pharma's push toward approval despite falling short on some secondary endpoints...On a call to discuss the findings, Kaivan Khavandi, M.D., Ph.D., GSK's global head of respiratory/immunology R&D, told Fierce Biotech that these secondary fails had been affected by a "significant placebo response, which is obviously an intrinsic challenge with patient-reported outcomes."... Full

As Sandoz Contract Winds Down, GSK Will Close Antibiotics Plant in UK

(9/9, Kevin Dunleavy, Fierce Pharma) ...With the expiration of a contract to produce antibiotic medicines for Sandoz, GSK will shutter a 75-year-old manufacturing facility in its home country. The U.K. pharma will close its plant in Ulverston in June of next year, terminating the employment of approximately 100...The GSK spokesperson added that the company is making a 2 million pound sterling ($2.6 million) donation to the community... Full

AbbVie Sues Rival BeiGene Over Alleged Theft of Cancer Therapy Secrets

(9/9, Mike Scarcella, Reuters) ...Pharmaceutical giant AbbVie has sued cancer treatment maker BeiGene in Chicago federal court, accusing it of stealing trade secrets to develop a competing cancer-fighting therapy after hiring away a former longtime senior AbbVie scientist...BeiGene in a statement on Monday denied AbbVie's allegations and said the company will "vigorously defend our intellectual property rights against this lawsuit."... Full

Doug Long On the State of U.S. Healthcare, Pharmacy Deserts and "Pretty Anemic" Number of Drug Launches | PBMI 2024

(9/9, Peter Wehrwein, Managed Healthcare Executive) ...Doug Long, vice president of industry relations at IQVIA, a frequent speaker at the PBMI Annual National Confernece and other pharmaceutical and managed care meetings, discussed what he sees as the fragile state of U.S. healthcare, pharmacy "deserts" and the relatively small number of new drug launches so far in this year... Full

Dynamic Pricing May Help Independent Specialty Pharmacies Shut Out of Large PBM Networks | PBMI 2024

(9/9, Peter Wehrwein, Managed Healthcare Executive) ...In a second excerpt from an interview conducted at the 2024 PBMI Annual National Conference in Orlando, Kerri Tanner, Pharm.D., chief pharmacy officer of PayerAlly, discusses how new companies are disrupting the specialty pharmacy marketplace and hope to create competition on price with large pharmacy benefit manager (PBM) specialty pharmacies... Full

Drug Price Reforms Still On The Table For Passage This Year, Schumer Says

(9/9, Gabrielle Wanneh, InsideHealthPolicy) ...Down to the last four months of an election year, Senate Majority Leader Chuck Schumer (D-NY) told his colleagues over the weekend there are still opportunities this year to pass bipartisan legislation aimed at bringing down the cost of insulin and other prescription drugs as they work to put together legislation to keep the government funded beyond the upcoming Sept. 30 deadline... Sub. Req’d

The Expected Consequences Of Price Controls

(9/9, Wayne Winegarden, Forbes) ...Potential IRA price controls add an additional unknown on biosimilar manufacturers – whether the federal government will impose restrictive price controls on the originator biologic – when it is deciding whether to invest the millions of dollars into the lengthy biosimilar development process. This unknown creates an additional risk that lowers the expected potential return from engaging in the long and costly biosimilar development process. These additional costs will dampen biosimilar competition and, consequently, reduce the potential savings... Sub. Req’d

Video: The Little-Known Bill That Made Drugs More Affordable

(9/10, Anna Yeo, STAT) ...In this video, we explain how the Hatch-Waxman Act works to extend brand-name drug patent protection and also facilitate generic drug market entry, but also how it is limited in its power. We also cover other patent extensions that are used to delay generic drug entry and the ways this can affect consumers... Full

PBM Executives Face Penalties if Their Testimony Goes Uncorrected

(9/9, Susan Morse, Healthcare Finance) ...The heads of three large pharmacy benefit managers have until tomorrow to respond to a House Committee or face perjury charges that could result in fines or even prison time, according to the letters sent by House Committee on Oversight and Accountability Chairman James Comer (R-Ky.)... Full

AMA Study: The 4 Largest PBMs Control 70% of the Market Nationally

(9/9, Paige Minemyer, Fierce Healthcare) ...AMA President Bruce Scott, M.D., said in a press release that the findings "warrant attention as Congress and the administration continue their work to protect patients and ensure prescription drugs remain affordable and accessible."... Full

ERIC Weighs Suing After Administration Leaves Much Of Mental Health Parity Rule Unchanged

(9/9, Sigi Ris, InsideHealthPolicy) ...An employer-sponsored insurance lobby signaled it might sue just hours after the Biden administration issued a long-awaited final mental health parity rule Monday (Sept. 9), saying while the final rule includes some changes called for by insurers it still exceeds the administration's statutory authority. A broad group of insurers likewise said the rule goes beyond the statute but stopped short of mentioning potential litigation, coming after a key House Republican warned last month the draft rule was on shaky ground after the Supreme Court axed its Chevron principle of deferring to agencies' interpretation of vague statutes... Sub. Req’d

US House Passes Bill to Blacklist Some China Biotech Firms

(9/10, Steven T. Dennis, Bloomberg) ...China hawks in the US House overcame a last-ditch lobbying effort and passed legislation Monday night that would blacklist Chinese biotech companies and their US subsidiaries. The bill, approved by a vote of 306 to 81, now goes to the Senate...Chinese Foreign Ministry spokeswoman Mao Ning said her nation opposed the bill, describing it in a regular press briefing in Beijing as potentially taking "discriminatory measures" against the nation's firms... Sub. Req’d

US Bill to Restrict Business with China's WuXi AppTec, BGI Passes House

(9/10, Karen Freifeld, Reuters) ...WuXi AppTec said in a statement it was "disappointed" in the House vote which it said "pre-emptively and unjustifiably designates our company without due process."...The targeted companies have all maintained the measure is based on false and misleading allegations and that it would limit competition. They deny posing any threat to U.S. national security and each say they should not be included in the bill... Full

House Passes Biosecure Act, Sending Chinese Biotech Ban to Senate

(9/9, Zachary Brennan, Endpoints News) ...The House's bill would force biopharma companies to cut ties or restrict their work with contract manufacturers WuXi AppTec, WuXi Biologics and three genetic sequencing companies by 2032...Complete Genomics told Endpoints News via email after the vote, "We are deeply disappointed but not entirely surprised that geopolitics instead of facts drove the House passage of the BIOSECURE Act, leaving the Senate in these final months of the session burdened with having to fix this broken and flawed bill."... Full

Investors Bet On India, Korea to Fill Gaps From US Biosecure Act

(9/10, Alex Gabriel Simon and Sangmi Cha, Bloomberg) ...Shares have surged for businesses in India, South Korea and Japan that are seen as positioned to seize the opportunity left by those Chinese companies, which generate billions of dollars in revenue each year from American clients...South Korea's Samsung Biologics, cited as a potential beneficiary of the Act by KB Securities Co. analyst Hye Min Kim, has seen inquiries of related contract development orders double since the amendment was introduced... Full

CDER Chief On Inspection Backlog: 2025 Will Be a 'Crucial Year'

(9/9, Zachary Brennan, Endpoints News) ...CDER director Patrizia Cavazzoni on Monday stressed that while the agency is looking to reduce its backlog of surveillance inspections, pre-approval inspections will continue to uncover cGMP issues, lamenting that the timing of those uncoverings is "obviously not optimal."...Speaking at a conference for manufacturers in Washington, she called 2025 "a crucial year for us to really get back to where we would like to be," and noted that the FDA uses a risk-based approach to selecting sites for inspections. She also noted that for-cause inspections have returned to pre-pandemic levels... Full

EMA, HMA Publish Large Language Model Principles for Regulators

(9/9, Ferdous Al-Faruque, Regulatory Focus) ...The European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) have agreed to a set of guiding principles for their staff when using large language models (LLM) to make regulatory decisions. Artificial intelligence (AI) virtual assistants or chatbots use LLMs to formulate results, and the agencies foresee regulators using such technology in their work... Full

China Continues Efforts to Enhance Drug Affordability

(9/10, Xinhua) ...Data revealed at a press conference in Beijing on Tuesday showed that since the introduction of the annual update system for the medical insurance drug catalog in 2018, 744 medicines have been added to the list. The catalog now includes 3,088 drugs, covering treatments for both common diseases and rare illnesses, according to the NHSA... Full

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