Wednesday, January 8, 2025

Teva Ordered Again To Delist Inhaler Patents From The Orange Book. But Is This The End?

(1/7, Urte Fultinaviciute, Generics Bulletin) ...On 20 December, the US Court of Appeals for the Federal Circuit affirmed a lower district court decision, which was announced in June, ordering the Israeli firm to delist five patents covering its ProAir HFA (albuterol) inhaler from the Food and Drug Administration's Orange Book. Teva swiftly appealed this decision, stating that it stood behind its intellectual property. This in return resulted in a civil investigative demand being sent to the Teva by the Federal Trade Commission... Sub. Req’d

Metsera Touts ‘Powerful' Weight Loss Results—Again

(1/7, Tristan Manalac, BioSpace) ...Months after posting weight loss of 7.5% at 36 days for patients taking MET-097i, Metsera releases mid-stage results of just over 11% average body weight reduction at 12 weeks, with no plateau and a promising safety profile. Just over three months after it commanded the industry's attention with impressive Phase I data, Metsera is back with more promising findings for its investigational subcutaneous GLP-1 therapy MET-097i, which in a Phase IIa readout on Tuesday showed strong weight reduction and an encouraging tolerability profile... Full

What's in a Claim? The Federal Circuit Rules on Orange Book Patent Listings

(1/8, Sara W. Koblitz, FDA Law Blog) ..."To list a patent in the Orange Book, that patent must, among other things, claim the drug for which the applicant submitted the application and for which the application was approved. And to claim that drug, the patent must claim at least the active ingredient. Thus, patents claiming just the device components of the product approved in an NDA do not meet the listing requirement of claiming the drug for which the applicant submitted the application."... Full

Biocon Biologics Completes One-Year as an Integrated Global Biosimilars Enterprise

(1/8, Pharmabiz.com) ...A Three-Stage Strategy: Preserve, Consolidate, Accelerate approach has helped to the preservation of value during the business transition in 2023, followed by consolidation of the business in 2024 while achieving profitable growth. The company has now stepped into the final stage of accelerated business growth in 2025 and beyond, he added. Following completion of the acquisition in November 2022, Biocon Biologics successfully navigated the complexities of integrating a global business which can often take 2-3 years and focused on preserving the value for all stakeholders... Full

Tanvex Takes A Hit On Trastuzumab With CRL In US

(1/8, Dave Wallace, Generics Bulletin) ...Tanvex has received disappointing news on its US filing for a Herceptin (trastuzumab) biosimilar, with the US Food and Drug Administration issuing the firm with a complete response letter over its TX05 trastuzumab candidate. The Taiwanese firm said the CRL for the breast cancer and gastric cancer treatment "cites certain issues to be addressed by the downstream manufacturer of TX05, which is a third-party service provider of Tanvex US for its drug product," adding that "Tanvex US is proactively discussing with the downstream manufacturer to address all the issues and reply to the US FDA as soon as possible."... Sub. Req’d

Sanofi Partners with Alloy Therapeutics to Make New CNS Drug

(1/7, Lei Lei Wu, Endpoints News) ...Sanofi has enlisted drug discovery company Alloy Therapeutics to develop an antisense oligonucleotide drug for a single, undisclosed central nervous system target. Sanofi will pay Alloy up to $27.5 million in upfront and near-term preclinical milestones, according to the biotech's Tuesday press release. Alloy could get up to more than $400 million in milestone payments as well as royalties... Sub. Req’d

J&J's New Cancer Combo Beats AstraZeneca's Tagrisso on Survival in Lung Trial

(1/7, Nicole DeFeudis, Endpoints News) ...Johnson & Johnson said its recently approved Rybrevant and Lazcluze combination therapy topped Tagrisso on overall survival in a Phase 3 trial, notching a key win in its rivalry against the AstraZeneca blockbuster. The company announced Tuesday that it expects first-line non-small cell lung cancer patients to see an improvement in median overall survival of more than one year compared to Tagrisso. The patients in the trial had two of the most common EGFR mutations, commonly associated with women and non-smokers... Sub. Req’d

Celltrion to Unveil Novel Drug Roadmap at JP Morgan Healthcare Conference

(1/8, Kim Hae-Yeon, The Korea Herald) ...Korean biosimilar giant Celltrion announced on Wednesday that it will present its vision and strategy for novel drug development at the 43rd JP Morgan Healthcare Conference next week. The event, recognized as the world's largest healthcare investment symposium, is set to take place Monday through Thursday in San Francisco, California. Over 8,000 participants and 550 biotech companies have reportedly been registered for the four-day event... Full

With a Major Patent Cliff Coming, Will JPM Play Host to Some Serious Deal-Making?

(1/8, Allison DeAngelis and Adam Feuerstein, STAT+) ...Between now and 2033, the patents on dozens of brand-name medications will expire, allowing generic drugmakers to begin selling cheaper versions. Drug companies stand to lose more than $400 billion in revenue as patents expire for Keytruda, Eliquis, Jardiance, Opdivo, and other blockbuster therapies. (By comparison, the last major patent cliff that hit the industry, in 2011, jeopardized around $250 billion in drug revenue.) One of the few tried-and-tested methods for navigating a patent cliff is to acquire startups and new drugs — and lots of them... Sub. Req’d

GSK and Pfizer's RSV Vaccines to Carry Warnings of Neurological Disorder Risk

(1/7, Reuters) ...GSK and Pfizer's respiratory syncytial virus (RSV) vaccines will carry warnings that they can increase the risk of developing a rare neurological disorder, the U.S. Food Drug Administration said on Tuesday. The regulator conducted a postmarketing trial which suggested increased risk of Guillain-Barré syndrome (GBS) 42 days following vaccination. However, the available evidence was insufficient to establish a causal relationship, the FDA said... Full

Generic Drugs With Subpar Potency Can Be Dangerous: Prognosis

(1/8, Anna Edney, Bloomberg) ...Okuda is a neurologist who specializes in multiple sclerosis at the University of Texas Southwestern Medical Center in Dallas. He had noticed the number of generic medications to treat MS were growing and wondered: Were his patients being harmed? He found six women being treated at the medical center for relapsing remitting multiple sclerosis who had experienced instances of worsening symptoms when they were switched from Novartis AG’s Gilenya to its generic, called by its active ingredient fingolimod. He and other researchers were able to test the generic fingolimod that three of the women had taken... Full

Mark Cuban Once Helped His College Friend Save Almost $10,000 on Prescriptions After a ‘Horrific Car Accident'

(1/7, Lindsey Leake, Fortune) ...Mark Cuban isn't solely on a mission to lower the price of popular prescription medications you might purchase from your favorite pharmacy. The billionaire entrepreneur and cofounder of the Mark Cuban Cost Plus Drug Co. wants to make so-called specialty drugs more accessible too. The Shark Tank alum discussed his disruption of the "opaque" pharmaceutical industry during last night's Fortune Brainstorm Tech dinner at CES in Las Vegas. Cuban directed much of his ire at pharmacy benefit managers (PBMs), third-party intermediaries between drug manufacturers and health insurance providers that he's accused of price-gouging at patients' expense. At dinner, he told Fortune's Andrew Nusca that PBMs' industry takeover extends to specialty pharmacies... Full

Stable Patient Satisfaction Found After Switching From the Humira or Biosimilar CT-P17

(1/7, Deana Ferreri, PhD, AJMC) ...A real-world study in France found patient satisfaction was stable after switching from either the reference product or a low-concentration adalimumab biosimilar to the adalimumab biosimilar CT-P17, a high-concentration, citrate-free formulation. More patients previously treated with an adalimumab biosimilar compared with the reference product reported increased satisfaction after switching... Full

Shakedown Lawsuits, Not Safety, Explain Drug Shortages

(1/7, AnneMarie Schieber, RedState) ...On October 31, 2023, U.S. Sen. Richard Blumenthal (D-CT) sent a letter to U.S. Food and Drug Administration (FDA) Commissioner Robert Califf, M.D. urging him to take "appropriate actions to investigate and recall products with unacceptable levels of benzene." Blumenthal wrote an "independent quality assurance company," a fancy phrase for a lab, found "unacceptable" high levels of benzene in popular over-the-counter acne treatment products in a study in March 2023. Benzene, Blumenthal pointed out, is a "known hormone disruptor and carcinogen."... Full

Drug Price Talks Provide an Early Test for Trump

(1/8, Maya Goldman, Axios) ...The Biden administration within days is expected to select the next batch of drugs that will be subject to Medicare price negotiations — a process that this time could include Novo Nordisk's blockbusters Ozempic and Wegovy. Why it matters: The political appeal of bringing down the price of the wildly popular drugs and other medicines for seniors could outweigh deep misgivings in Republican circles about one of Democrats' most significant health policy achievements... Full

Inflation-Adjusted U.S. Brand-Name Drug Prices Fell for the Seventh Consecutive Year as a New Era of Drug Pricing Dawns

(1/7, Adam Fein, Drug Channels) ...As I predicted two years ago, the combined impact of changes to Medicaid rebates, the Inflation Reduction Act (IRA), and novel formulary access strategies have led multiple manufacturers to pop the gross-to-net bubble for high-list/high-rebate products. Consider the 18 products with list-price cuts shown below. Other drugmakers have reduced the rate of price increases, thereby inflating the bubble more slowly... Full

Drugmakers Cut Some List Prices, Shrinking Room for Rebates in Cancer, Asthma and Diabetes

(1/7, Alexis Kramer, Endpoints News) ...Bayer's Nexavar and Boehringer Ingelheim's Spiriva are among a handful of drugs with reduced US list prices for the new year, according to a Tuesday analysis that showed average prices growing at their slowest rate in years. Bayer cut the list price of its cancer drug Nexavar in half, effective Jan. 1, according to data compiled by Drug Channels Institute (DCI). The list prices for Merck's diabetes drugs Janumet XR and Januvia were cut by 42.4%. And Boehringer reduced the list price of its asthma drug Spiriva by 36.7% and Atrovent, which is used to treat chronic obstructive pulmonary disease, by 35.0%... Sub. Req’d

Generic GLP-1 Drugs Could Help Medicare Drive a Harder Bargain for Ozempic and Wegovy

(1/8, STAT+) ...The advent of the first generic GLP-1 drugs could help Medicare negotiate a lower price for the highly sought after diabetes and obesity medication semaglutide, according to experts familiar with the price-negotiation program and STAT's review of documents from the first round of negotiations. The Food and Drug Administration approved generics for the diabetes drugs exenatide and liraglutide in November and December. While those drugs don't work as well as semaglutide, their much lower costs could give Medicare leverage to push for lower prices for semaglutide, two experts said... Sub. Req’d

As Finance Chair, Crapo Says He Will Follow Through On Doc Fix, PBMs

(1/7, Jessica Karins, Inside Health Policy) ...As the next chair of the Senate Finance Commitee, Sen. Mike Crapo (R-ID) says his priorities will include pushing for pharmacy benefit manager (PBM) reform, telehealth extensions, a long-term fix for the physician fix schedule and mental health care. On drug pricing, Crapo said the Finance Committee will "conduct aggressive oversight of the so-called Inflation Reduction Act and enact policies that mitigate the adverse consequences of this law on patients, innovators and taxpayers." He also said it will fight high drug costs by aiming to modernize Medicare prescription drug benefits... Sub. Req’d

FTC: Second Interim Report On PBMs Coming Under Kahn's Watch

(1/7, Gabrielle Wanneh, Inside Health Policy) ...The open meeting will be Khan's last as FTC chair, and it's unclear whether Andrew Ferguson, tapped by President-elect Donald Trump to chair FTC, will follow through on Kahn's aggressive oversight of the pharmaceutical middlemen. Ferguson made no mention of his plans for enforcement against deceptive or anticompetitive PBM business practices in his pitch to chair the commission, but he did call for FTC to be selective in its anti-merger efforts and had abstained from voting for FTC to release its first interim report blasting PBMs last July... Sub. Req’d

Congress' PBM Bill Flops: Why Its Failure May Be a Blessing in Disguise.

(1/7, Rita E. Numerof, RealClear Health) ...Following the FTC report and the lawsuit the agency brought against the big three PBMs two months later, legislators were galvanized to pass PBM legislation. Many industry insiders expected that some action would be taken to address these PBM related issues in the lame duck session. At the 11th hour they slipped 38 pages into the 1500-page CR bill. Maybe they were hoping no one was looking or at least hadn't read it. Maybe it was reminiscent of Nancy Pelosi's famous line in advance of the March 2010 vote on the Accountable Care Act, "we have to pass it to know what's in it."... Full

FDA Sets an Efficacy Threshold for Future Weight Loss Drugs

(1/7, Zachary Brennan, Endpoints News) ...New anti-obesity drugs should meet a minimum level of weight loss to be considered for approval, the FDA said Tuesday, taking the rare step of proposing an efficacy threshold for future products. In a 21-page draft guidance, the agency said drugs that hope to compete in the blockbuster class will have to show at least 5% weight loss after a year of steady "maintenance" dosing compared with a placebo group, and the difference will have to be statistically significant... Sub. Req’d

FDA Releases Flurry Of Guidance Docs As Biden Admin Wraps Up

(1/7, Jessica Karins, Inside Health Policy) ...FDA is releasing a barrage of new guidance documents in the final days of the Biden administration as current officials rush to finalize policy priorities during a time of year when policymaking is typically slow, but President-elect Donald Trump is expected to put many of President Joe Biden's midnight policies on hold and usher in a very different regulatory paradigm at the agency when he enters the White House in less than two weeks. The guidance documents span from oversight of device and pharmaceutical artificial intelligence, to promotion of off-label uses, to compounding, to weight-loss drugs and much more... Sub. Req’d

FDA Finalizes Advanced Manufacturing Technology Designation Guidance

(1/7, Joanne S. Eglovitch, Regulatory Focus) ...The US Food and Drug Administration (FDA) has finalized a guidance to assist sponsors interested in participating in the Advanced Manufacturing Technology (AMT) designation program. In response to feedback, FDA has revised its guidance to clarify the Advanced Manufacturing Technology (AMT) designation process, the roles of various entities involved in the program, and its application to Biologics License Applications (BLA) applicants to reference an AMT designation within their applications... Sub. Req’d

Leaving FDA, Califf is Unapologetic — And Warns of Staff Departures

(1/8, Matthew Herper, STAT+) ...The clock is ticking down to what could be a volatile period for the FDA. Robert F. Kennedy Jr., President-elect Donald Trump's choice to be secretary of health and human services, has used anti-vaccine rhetoric for decades and, before the 2024 election, warned FDA employees on social media to preserve "their records." But Marty Makary, the presumptive next FDA commissioner, is seen as a more stable choice to run the agency. Chaos could loom ahead — or not... Sub. Req’d

Bipartisan Lawmakers Introduce Save Local Pharmacies Act

(1/8, Charlotte Rene Woods, Virginia Mercury) ...A bipartisan group of lawmakers helmed by Sen. Aaron Rouse, D-Virginia Beach and Del. Katrina Callsen, D-Charlottesville, introduced the Save Local Pharmacies Act, which lawmakers will take up in this year's legislative session, starting Wednesday. The proposal would realign Virginia's Medicaid pharmacy benefit under a single state-contracted pharmacy benefits manager. "Independent pharmacies are in an existential crisis," said Blacksburg-area pharmacist Jeremy Counts when he called into a rural healthcare committee meeting last summer... Full

Spanish Health Ministry Targets Efficiency With New Medicine Pricing Rules

(1/7, Francesca Bruce, Pink Sheet) ...The Spanish health ministry is consulting on a draft royal decree to update and clarify key aspects of existing regulation for setting prices and financing medicines available on the national health system (SNS). Measures proposed include the possibility of reviewing prices of medicines that are already reimbursed and establishing criteria for authorizing accelerated reimbursement... Sub. Req’d

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