Friday, March 1, 2024

Pharma Companies Ask Court Not to Break Up US States' Price-Fixing Lawsuits

(2/29, Mike Scarcella, Reuters) ...Drug companies Upshur-Smith, Teva, Glenmark and more than a dozen others in a petition urged the Philadelphia-based 3rd U.S. Circuit Court of Appeals to keep Connecticut and 45 other states a part of the antitrust litigation in Pennsylvania...Upshur-Smith declined to comment on Thursday, and Teva and Glenmark did not immediately respond to requests for comment. The companies have denied the states' claims. The Connecticut attorney general's office called the drugmakers' appeal a "delay tactic" and said the states were prepared to move ahead in Connecticut... Full

What's Next? Five Things To Look Out For In March

(3/1, Dean Rudge, Generics Bulletin) ...Other recent developments include Alvotech penning a fresh a global licensing deal with Kashiv BioSciences for the firm's ADL018 proposed omalizumab biosimilar, having earlier terminated an alliance with BiosanaPharma. With a firm focus on biosimilars under CEO Richard Francis, Teva is also developing a biosimilar that is currently in Phase III clinical trials. Study completion is estimated for June this year... Global Sub. Full

EuroAPI's Blueprint for ‘Leaner' Operations Includes Dropping Products, Potential Layoffs and Sites Put On Ice

(2/29, Anna Brown, Endpoints News) ...EuroAPI is counting on 2024 to be its "year of transition" as the small molecule producer plans to discontinue API assets, potentially make layoffs and "mothball" or divest sites. Its restructuring project, dubbed FOCUS-27, will be driven by its newly appointed CEO, Ludwig de Mot...The company noted on Wednesday that 16 customer CDMO projects were stopped, paused or delayed by customers throughout 2023, with two of those projects being late-stage Sanofi assets. Sanofi will "significantly" cut its API volumes for 2024 and 2025, well below the provider's expectations which, according to EuroAPI's full-year earnings release, is "weighing on the profitability" of its API business... Full

Alvotech Raises Further Funds After FDA Green Light

(2/29, David Wallace, Generics Bulletin) ...Hot on the heels of Alvotech's long-awaited US Food and Drug Administration approval for Simlandi (adalimumab-ryvk) – the first interchangeable, citrate-free, high-concentration biosimilar rival to Humira approved in the US – the developer has announced a share sale that will bring in $166m...Alvotech anticipates a US FDA approval for ustekinumab on April 16, 2024 ahead of an expected launch via local partner Teva "no later than February 21, 2025" under a settlement with the originator... Global Sub. Full

With J&J Settlement, Biocon Biologics Gets a License to Challenge Stelara in the US

(2/29, Eric Sagonowsky, Fierce Pharma) ...Thursday, Biocon Biologics said it has inked a Stelara patent settlement with J&J. With the deal, Biocon Biologics has secured a license to allow its biosimilar to enter the U.S. market in February 2025, pending an FDA approval. The prospect, called Bmab 1200, is currently under review at the FDA, the biosimilar maker said in a release... Full

Biocon Stelara Settlement Places Firm Among Earlier US Rivals

(3/1, David Wallace, Generics Bulletin) ...The FDA has already accepted the company's biologics license application for Bmab 1200, with Biocon Biologics CEO and managing director Shreehas Tambe having previously indicated in late 2023 that the biosimilar was "in the process of getting filed this year." Along with the firm's denosumab biosimilar, Tambe said these were "two assets, in addition to aflibercept, where we believe that there are sizeable opportunities which can drive growth." Stelara brought in sales of $10.9bn for Johnson & Johnson in 2023, of which around $7bn came from the US market alone... Global Sub. Full

India's Suven Pharma, Cohance Merge to Boost Contract Drug Manufacturing Services

(2/29, Rishika Sadam, Reuters) ...Indian contract drug manufacturer Suven Pharmaceuticals, opens new tab said on Thursday it will merge with Cohance Lifesciences in an all-share deal, as it looks to further scale up its contract and development manufacturing services business...Under the deal, all shareholders of privately held Cohance will be issued 11 shares of Suven for every 295 shares of Cohance based on the swap ratio, Suven said on Thursday... Full

Pfizer Fleshes Out Oncology Strategy, Targeting 8 Blockbuster Cancer Drugs by 2030

(2/29, Angus Liu, Fierce Pharma) ...The company aims to have at least eight blockbuster cancer drugs by 2030, Pfizer's newly minted chief oncology officer, Chris Boshoff, Ph.D., said during an investor event Thursday as he unveiled the strategic priorities. By then, Pfizer hopes to double the number of patients treated with its innovative cancer medicines from about 2.3 million in 2023. The new plan also sees Pfizer focusing on four main cancer types—breast cancer, genitourinary cancer, blood cancer, and thoracic cancers—all of which the company already has commercial products in... Full

Dr. Reddy's Named As Defendant in a Complaint in New Jersey District Court Over gRevlimid

(3/1, Ekta Batra and Hormaz Fatakia, CNBC TV 18) ...The complaint was filed by Walgreen Co., Kroger Specialty Pharmacy Inc., and CVS Pharmacy Inc., asserting claims under the Federal Antitrust Law. These companies have alleged that Dr. Reddy's, acting in connection with Celgene Corporation, Bristol-Myers Squibb Co., Natco Pharma Ltd., and Teva Pharmaceuticals USA, Inc., improperly restrained competition and maintained a shared monopoly in the sale of brand and generic Revlimid through their settlements of patent litigations... Full

Drugmaker Endo Reaches $465 Mln Bankruptcy Settlement with US

(2/29, Dietrich Knauth, Reuters) ...Bankrupt drugmaker Endo International will pay up to $465 million to settle the federal government's law enforcement, tax, and healthcare cost claims, the U.S. Department of Justice said on Thursday...Damian Williams, U.S. Attorney for the Southern District of New York, said on Thursday that bankruptcy is not a "free pass to evade responsibility for criminal misconduct, civil fraud, or taxes." The DOJ settlement ensures that Endo takes responsibility for its past misconduct, and it preserves Endo's previous agreements to fund state and local opioid addiction treatment programs and make payments to individuals harmed by the opioid epidemic, Williams said... Full

Judge OKs $385 Million Antitrust Settlement Over Suboxone Plot

(2/28, Katie Arcieri, Bloomberg Law) ...A federal judge approved a $385 million settlement between a group of direct purchasers and Indivior Inc. over claims the drugmaker abused its monopoly over the Suboxone opioid addiction treatment. Judge Mitchell S. Goldberg of the US District Court of the Eastern District of Pennsylvania on Tuesday called the $385 million settlement "fair, reasonable, and adequate," and said it provides plaintiffs who bought the drug with immediate recovery without subjecting them to the rigors of a difficult trial... Sub. Req'd

US FDA Slaps Aurobindo Pharma's Telangana Injectable Facility with 7 Observations

(2/29, Neethi Rojan, Money Control) ...Aurobindo Pharma said on February 29 that the United States Food and Drug Administration has slapped the company's injectable facility in Telangana state, with seven observations. In an exchange filing, Aurobindo Pharma said the the US FDA inspected the injectable facility of Eugia SEZ Pvt. Ltd. from February 19-29. Eugia is a a 100% step-down subsidiary of Aurobindo Pharma Ltd. The company said that these observations are procedural in nature and will be responded to within the stipulated time... Full

US FDA Issues 4 Observations for Biocon Biologics' Insulin Facility

(2/29, Neethi Rojan, Money Control) ...The United States Food and Drug Administration issued four observations for Biocon Biologics facility, the pharma company informed stock exchanges on February 29. The inspection was at Biocon Biologics Limited's Biocon Campus (Site 1) facility between February 20-28, 2024. This inspection pertains exclusively to the rh-Insulin (rhI) Drug Substance supply to a customer for veterinary use... Full

Pharma Lags Behind Healthcare in AI Adoption, But Many Expect Wider Use in Next Few Years, Study Finds

(2/29, Beth Snyder Bulik, Endpoints News) ...Pharma companies are trailing behind healthcare in AI adoption by a wide margin, according to a new study. Only 20% of pharma professionals versus 40% of healthcare providers say the new technology is already in use, according to management consultancy Berkeley Research Group's report... Full

Pfizer Says its RSV Shot is Protective Through a Second Year

(2/29, Michael Erman, Reuters) ...Pfizer on Thursday said a single dose of its new respiratory syncytial virus vaccine Abrysvo maintained its ability to protect against the illness through a second year of respiratory disease season. The company said in a press release that the vaccine's efficacy against RSV-associated lower respiratory tract disease with three or more symptoms was 77.8% through season two, compared with efficacy of 88.9% after the first RSV season, which led to the shot's U.S. approval... Full

RSV Vaccines May Be Linked to Small Increased Risk of Developing Guillain-Barré Syndrome, Data Suggest

(2/29, Helen Branswell, STAT) ...At a meeting Thursday of the Advisory Committee on Immunization Practices, vaccine safety experts from the two agencies presented data that showed what appears to be an elevated rate of GBS, as the condition is called, among people who got the Pfizer vaccine, although there were also cases detected among people who got the GSK product. But the experts cautioned that it is too early to determine if there is a true increased risk of developing GBS after RSV vaccination, or to quantify the size of that risk, if it exists... Full

Are Alternatives to Addictive Opioids on the Way?

(3/1, David Wainer, The Wall Street Journal) ...In recent decades, scientists identified genetic mutations that made people either feel too much pain or made them unable to sense it...The discovery of the mutated gene, which encodes sodium channels that regulate the transmission of pain signals to the brain, offered a tantalizing target because it represented a way to potentially block pain at its source with limited side effects. But relieving pain by blocking these channels, known as Nav1.7 and Nav1.8, has proved difficult, and companies including Teva, Roche and Biogen have undertaken clinical trials that failed to demonstrate conclusive evidence of pain relief... Sub. Req'd

Change Healthcare Cyberattack Outage Could Persist for Weeks, UnitedHealth Group Executive Suggests

(2/29, Brittany Trang, STAT Plus) ...The outage caused by the Change Healthcare cyberattack could last weeks, a top UnitedHealth executive suggested in a Tuesday conference call with hospital cybersecurity officers, according to a recording obtained by STAT. UnitedHealth Group Chief Operating Officer Dirk McMahon said the company is setting up a loan program to help providers who can't submit insurance claims while Change is offline. He said that program will last "for the next couple of weeks as this continues to go on."... Sub. Req'd

Cyberattack On UnitedHealth Still Impacting Prescription Access: "These Are Threats to Life"

(2/29, Nicole Sganga and Andres Triay, CBS News) ..."I can tell you that this cyberattack has affected every hospital in the country one way or another," said John Riggi, national advisor for cybersecurity and risk at the American Hospital Association. "It's not a data crime, it's not a white-collar crime, these are threats to life," Riggi added. In a since-deleted post on the dark web, a Russian-speaking ransomware group known as Blackcat claimed responsibility, alleging they stole more than six terabytes of data, including "sensitive" medical records... Full

IRA Innovation Debate Showcased At House Hearing On Rare Disease Legislation

(2/29, Cathy Kelly, Pink Sheet) ...The mainly partisan disagreements in Congress over whether the Medicare price negotiation program established by the Inflation Reduction Act will undercut pharmaceutical industry innovation took center stage at a House Energy & Commerce Health Subcommittee hearing on legislation to support rare disease patients on February 29. Two bills that would revise the law as it pertains to the negotiation program were considered by the committee and prompted a good deal of discussion. Both are co-sponsored by Reps. Wiley Nickel, D-NC, and John Joyce, R-PA... Sub. Req'd

House Committee Debates IRA Changes That Would Impact Orphan Drugs and Other Areas

(2/29, Nicole DeFeudis, Endpoints News) ...In a three-hour hearing by the House Committee on Energy and Commerce on Thursday, representatives were particularly focused on the bipartisan Optimizing Research Progress Hope And New (ORPHAN) Cures Act and Maintaining Investments in New Innovation Act...Rep. Frank Pallone (D-NJ), who helped write the drug pricing components of the IRA, argued on Thursday that the orphan exclusion "was not intended to be an escape hatch for manufacturers to avoid negotiating fair prices and game the system."... Full

HHS Issues New Guidance for Medicare Prescription Drug Program

(2/29, Tony Pugh, Bloomberg Law) ...Thursday's final Part 1 guidance targets drug plans that participate in the program. The new guidelines cover things such as how to opt-in to the program, identifying Part D enrollees who could benefit from it, protections for program participants, and data collection requirements. The guidance requires drug plans to process election coverage requests within 24 hours, and to remind pharmacies to inform eligible customers about the program... Sub. Req'd

House Looks to Weaken Medicare Negotiation

(2/29, Rachel Cohrs, STAT) ...The White House is hosting a listening session on PBM reform on Monday, with invitees including the namesake of the Mark Cuban Cost Plus Drug Company Mark Cuban and FTC Chair Lina Khan, my colleague Ed Silverman scooped yesterday. The listening session comes as efforts to reform PBM practices have stalled amid disagreements on Capitol Hill over their scope. Read more, including what Cuban told Ed his agenda would be going into the meeting... Full

Sanders Won't Let Facts Get In Way of a Good Pharma Shaming

(2/29, Sally Pipes, Newsmax) ...There's little doubt that price controls will reduce what Medicare beneficiaries pay for drugs in the short term. But such controls will chill investment into the next generation of therapies and cures. It would be far more economically efficient to inject transparency into the prescription-drug purchasing process...If Sen. Sanders were really interested in why the prices of brand-name drugs are rising, he would've invited those middlemen, rather than the drug makers, to tell him why... Full

AMCP CEO Susan Cantrell Addresses Complex Causes of High Drug Prices and Advocates for Multi-Stakeholder Solutions in US Healthcare

(2/29, Briana Contreras, Managed Healthcare Executive) ...AMCP CEO Susan Cantrell spoke with Managed Healthcare Executive about the challenges of pinpointing specific causes for high drug prices. Cantrell emphasized the crucial role of innovation in driving prescription drug costs, sharing the exciting advancements in therapies for long-standing health issues. However, she did caution against some policy solutions that might intervene in any innovations... Full

What Does America's Crackdown On Chinese Firms Mean for the U.S. Biotech Sector?

(2/29, John Wilkerson, STAT Plus) ...The Biosecure Act would direct the White House, in consultation with certain agencies, to develop a list of "biotechnology companies of concern." The bill requires four specific companies to be included: BGI Genomics, MGI, Complete Genomics, WuXi AppTec, and any subsidiary, parent affiliate, or successor of these four companies... Sub. Req'd

Surely You Must be Kidding, PTO?!? "No, and Don't Call Me Shirley!" – The Seemingly Slapstick (But Yet Unfunny) World of Recent Patent Term Extension Decisions (PART 2)

(3/1, Kurt R. Karst, FDA Law Blog) ...Today, we move on to Part 2 (or "Part Deux" in homage to the 1993 comedy "Hot Shots! Part Deux," which starred Lloyd Bridges, who also starred in the 1980 movie "Airplane!" referenced in Part 1 of our series) concerning the PTO's position and recent decisions on PTE applications for patents covering products approved—and then withdrawn years later—under the Federal Food, Drug, and Cosmetic Act's Accelerated Approval provisions (as well as the Agency's corresponding regulations, which actually preceded the statutory provisions)... Full

European Parliament Supports Explicit Patent Linkage Ban

(2/29, Ian Schofield, Pink Sheet) ...An explicit ban on patent linkage would ensure that competition to originator drugs is not delayed, according to off-patent industry group Medicines for Europe. The EU off-patent industry group, Medicines for Europe, has welcomed a decision by the European Parliament to adopt a proposal calling for an explicit ban on patent linkage at its plenary session on February 28... Sub. Req'd

EU Parliament Backs Plan To Allow Pre-Grant Opposition To Patent Extension Requests

(2/29, Ian Schofield, Pink Sheet) ...Members of the European Parliament have ignored pleas from the EPP political group and the German Federal Council to drop a proposal allowing third parties to oppose the granting of a supplementary protection certificate. One of the more controversial changes in the European Commission's proposals for streamlining the granting of supplementary protection certificates for medicines is the introduction of a procedure allowing objections to be lodged before a decision to grant an SPC has been made... Sub. Req'd

HTA Evidence Used By England's NICE ‘Consistently Poor'

(2/29, Eliza Slawther, Pink Sheet) ...An analysis spanning two decades found that 65% of health technology assessments in England were based on evidence of poor or unacceptable quality, raising concerns around the efficacy of drugs reaching patients. Nearly two thirds of the clinical data used by England's health technology assessment body NICE during technology appraisals of pharmaceutical products between the years 2000 and 2019 was found to be of poor quality, according to a new research paper published in the BMJ by non-profit research organization Consilium Scientific... Sub. Req'd

Germany's Confidential Pricing Move Could Protect Companies From Potential Trumpian US Reference Pricing

(2/29, Francesca Bruce, Pink Sheet) ...Germany's draft Medicines Research Law if passed would allow companies to keep discounted reimbursement drug prices confidential. The move would give companies more pricing protection in launch markets that reference prices in Germany to set their own prices, potentially including the US if Donald Trump wins this year's US general election says Alexander Natz, secretary general of EUCOPE, which represents small and mid-sized pharmaceutical and biotech companies in Europe... Sub. Req'd

Canada's Prescription Drugs Plan Will Not Impact 2024/25 Budget, Minister Says

(2/29, Steve Scherer and Ismail Shakil, Reuters) ...Canada's Liberal government on Thursday introduced the broad outline of a national scheme to cover the cost of prescription drugs and said it will not mean much extra spending in the upcoming budget year, the health minister said. The first drugs to be covered by the plan will be birth control, including the so-called day-after pill, and insulin for diabetics... Full

Shelley Moves Up To Chair Canadian Association

(2/29, David Wallace, Generics Bulletin) ...Canada's CGPA has named Ray Shelley, president of Apotex Canada, as the off-patent industry association's chair. At the same time, Sandoz Canada president and general manager Michel Robidoux has been elected vice-chair...Speaking as he was named as chair, Shelley underlined that "our industry's focus remains ensuring a stable, predictable market for our sector, and the continued supply and introduction of cost-saving generic prescription medicines for Canadians."... Global Sub. Full

WHO Launches Pharmaceutical Quality Assurance Guidelines, 10th Edition

(2/29, World Health Organization) ...The 10th edition of the Quality assurance of pharmaceuticals: a compendium of guidelines and related materials is an essential resource for the global healthcare community, designed to strengthen pharmaceutical standards worldwide. The compendium, developed for national regulatory authorities, pharmaceutical manufacturers, healthcare professionals, and procurement agencies, is instrumental in upholding the globally acceptable standards of good manufacturing practices and inspections. With forty-six guidelines, including eight new and ten revised ones, it provides a comprehensive framework for enhancing regulatory systems and international standards for pharmaceutical quality assurance... Full

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