Monday, June 17, 2024

Teva Again King of Tel Aviv Castle

(6/17, Netanel Ariel, Globes) ...The share price of Teva Pharmaceutical Industries has risen by 130% in the past year...The rise in Teva's share price is largely due to the company's own efforts. It underwent far-reaching changes under its previous CEO, Kare Schultz: it cut costs, introduced efficiency measures, closed plants, laid of more than 15,000 employees, and signed a settlement of the claims against it in the opioids affair. Now, under its current CEO Richard Francis, Teva is talking about growth, new products, and streamlining its portfolio. In addition, in the past year it has received approvals from the US Food and Drug Administration for generic versions of several drugs. In 2023, for the first time in five years, Teva recorded growth in revenue, and for several successive quarters it has beaten analysts' estimates... Full

Teva Accuses Corcept of Monopolizing the Market for Korlym

(6/14, Dulan Lokuwithana, Seeking Alpha) ...Teva Pharmaceutical has filed a lawsuit accusing Corcept Therapeutics of engaging in antitrust behavior in marketing its lead product, Korlym, for a rare condition known as Cushing's syndrome..."The antitrust laws do not tolerate this state of affairs," the Israeli drugmaker said, seeking judicial intervention to restore competition and remedy the damages it has already incurred... Full

U.S. Drug Shortages Worsen to Reach a Decade High: Report

(6/15, Dulan Lokuwithana, Seeking Alpha) ...Based on its AI-based Medicine Supply Map, USP identified a "severe risk of shortage" for 91% of generic sterile injectables in 2023, including 58% of injectables that had recently gone into shortage. "Economic pressures, especially the very low prices that generics manufacturers recover for many medicines, along with contracts that are frequently broken, have left our generic medicine supply chain fragile," said Anthony Lakavage, USP's head of Global External Affairs...Adderall, manufactured by companies including Teva Pharmaceutical, Amneal Pharmaceuticals, and Novartis spinoff Sandoz, has been in shortage for almost two years... Full

Is There a Link Between Hotter Temps and Increased Migraine Headaches?

(6/14, Cedric Ricks, University of Cincinnati College of Medicine) ...As temperatures rise, so do chances for migraine attacks, according to a new study from a team of researchers at the University of Cincinnati College of Medicine, Icahn School of Medicine at Mount Sinai, Errex Inc. and Teva Pharmaceuticals USA. Inc... Full

Pfizer Calls For Sustainable Approach To Ensure Viability Of Biosimilars Market

(6/14, David Wallace, Generics Bulletin) ...Having in the first part of his interview with Generics Bulletin spoken about how biosimilars fit into Pfizer's wider business, the second part saw Barry Chester, the firm's global commercial lead for supportive care oncology, reflect on the obstacles to biosimilar market sustainability and how these can be overcome... Global Sub. Full

Sandoz Canada Expands Its Portfolio With Generic Vyvanse Launch

(6/14, Urte Fultinaviciute, Generics Bulletin) ...Sandoz Canada continues to broaden its generics portfolio with a recent launch of lisdexamfetamine capsules, a generic rival to Takeda's Vyvanse...According to Health Canada's drug product database, several other companies – including Apotex, Jamp, Pro Doc, Taro and Teva – also now have approved generic lisdexamfetamine products in the country... Global Sub. Full

Takeda Circles Leukemia Rival to Novartis' Scemblix in Up to $1.3B Deal with Ascentage

(6/14, Zoey Becker, Fierce Pharma) ...Thanks to an agreement with Ascentage Pharma, Takeda may later choose to in-license the Chinese biotech's olverembatinib, which is being developed for chronic myeloid leukemia along with "other hematological cancers," Takeda said in a press release. If the option is exercised, Takeda can license global development and commercialization rights in all territories outside of Greater China and Russia... Full

Hikma Adds Scale to US Injectables Business with Xellia Acquisition

(6/17, Jeremy Cutler, Alliance News) ...Hikma, the London-based pharmaceuticals company, said it has agreed to buy parts of Xellia's US finished dosage form business and assets, including a commercial portfolio and pipeline of differentiated products, a manufacturing facility in Cleveland, Ohio, sales and marketing capabilities, and an R&D centre in Croatia...Hikma said the deal supports the long-term growth of its injectables business and diversifies its US portfolio and pipeline, adding a range of ready-to-use products... Full

Samsung Bioepis' Epysqli Proves Clinical Equivalence to Soliris at European Meet

(6/17, Lee Han-soo, Korea Biomedical Review) ...Samsung Bioepis said it presented the results of a post-hoc analysis of a phase 3 clinical trial of Epysqli (ingredient: eculizumab), a biosimilar referencing Soliris, at the European Hematology Association, which was held in Madrid, Spain, from last Thursday to Sunday... Full

Celltrion Submits IND for P3 Study of Keytruda Biosimilar in US

(6/17, Lee Han-soo, Korea Biomedical Review) ...Celltrion said it submitted an investigational new drug (IND) application to the U.S. FDA for the phase 3 clinical trial of CT-P51, its Keytruda (ingredient: pembrolizumab) biosimilar..."The global phase 3 IND submission for CT-P51 will help the company expand its oncology portfolio and secure additional future growth drivers," a company official said. "Given the explosive growth of the global immunotherapy market, we anticipate significant revenue potential for CT-P51."... Full

Alembic Pharma Gets USFDA Nod for Icatibant Injection

(6/17, Business Standard) ...The approved drug is therapeutically equivalent to the reference listed drug product, Firazyr Injection of Takeda Pharmaceuticals U.S.A., Inc. Icatibant injection is indicated for the treatment of acute attacks of hereditary angioedema in adults 18 years of age and older. This is the first peptide product approval from the USFDA received by the company... Full

Regeneron Scores Injunctions in Eylea Biosimilar Patent Fight

(6/14, Adam M. Taylor, Bloomberg Law) ...Samsung Bioepis Co. was hit with a preliminary injunction in Regeneron Pharmaceuticals Inc.‘s patent-infringement lawsuit over proposed biosimilars to its Eylea age-related macular degeneration treatment, days after Mylan Pharmaceuticals Inc. and Biocon Biologics Inc. received permanent injunctions. Chief Judge Thomas S. Kleeh of the US District Court for the Northern District of West Virginia granted Regeneron's requests for the injunctions, according to sealed docket entries Friday and June 11... Sub. Req'd

J&J Win in Patent Suit Over Schizophrenia Drug Upheld by Judge

(6/14, Peter Hayes, Bloomberg Law) ...A trial win by Johnson & Johnson's Janssen unit in a patent infringement suit over its blockbuster schizophrenia drug, Invega Sustenna, will stand against Tolmar Inc., a federal judge ruled. Finding none of Tolmar's arguments "persuasive," Judge William C. Bryson of the US District Court for the District of Delaware denied Tolmar's motion for reconsideration of his bench trial ruling that the patent was valid. Tolmar had conceded infringement of the patent before trial... Sub. Req'd

Biocon's Andhra Pradesh Facility Gets 3 USFDA Observations

(6/15, Business Standard) ...Biocon said that US Food and Drug Administration issued three observations after the good manufacturing practices inspection conducted at its API manufacturing facility situated at Visakhapatnam, Andhra Pradesh. The good manufacturing practices was conducted on June 14, 2024 and closed the inspection with three observations. The company said that it will respond to the USFDA within the stipulated timeframe... Full

ADHD Drug Shortage Could Worsen After Arrests Of 2 Telehealth Executives, CDC Warns

(6/14, Arianna Johnson, Forbes) ...Following the Thursday arrests of two telehealth executives who were working with the company Done Global Inc., the Centers for Disease Control and Prevention issued a health advisory warning the U.S. attention-deficit/hyperactivity disorder medication shortage may worsen...The FDA blamed "increased prescribing potentially related to the growth in telemedicine, supply chain issues, manufacturing and quality issues and business decisions of manufacturers" for contributing to the ongoing shortages. It also blamed manufacturers like Teva Pharmaceuticals'—the maker of Adderall—inability to meet market demand... Full

Ambitious Federal Study Failed to Curb Opioid Deaths, NIH Announces

(6/16, Lev Facher, STAT) ...In 2019, amid an ever-worsening drug crisis, the federal government launched a research study with an ambitious goal: to lower opioid overdoses in participating communities by 40% using evidence-based interventions like distributing naloxone and providing access to addiction medications. But communities that implemented the public health strategies did not see a statistically significant reduction in opioid overdose deaths, according to data published Sunday in the New England Journal of Medicine... Full

Out of Mavericks Spotlight, Mark Cuban Now Aiming at ‘F—ing Up' Pharmacy Industry

(6/14, David Aldridge, The New York Times) ...Cuban said more than two million people have used [Cost Plus Drugs] since its founding, and it now buys or produces more than 2,500 drugs, most of them generics. He said he's willing to deficit spend for the foreseeable future. "We're not losing that much money," he said. "And if we keep going the way we're going, I'll make a little money. And we'll use it to add more drugs to our factories, so we can make more."... Sub. Req'd

Sanders Drops Call To Subpoena Novo President On U.S. GLP-1 Drug Prices

(6/14, Maaisha Osman, InsideHealthPolicy) ...Senate health committee Chair Bernie Sanders (I-VT) dropped his call to subpoena Novo Nordisk's North American operations president to testify on why the company charges high U.S. prices for its type-2 diabetes and obesity drugs, Ozempic and Wegovy, after the Danish company's global CEO, Lars Fruergaard Jørgensen, confirmed he will testify on a solo panel at a hearing scheduled for early September... Sub. Req'd

Sanders Drops Subpoena Effort After Novo Nordisk CEO Agrees to Testify

(6/14, Joseph Choi, The Hill) ...Sanders announced earlier this week that he would hold a vote to subpoena Doug Langa, the executive vice president of North America operations for Novo Nordisk, because the company has "repeatedly denied" requests to appear..."I enjoyed the opportunity of chatting with Mr. Jørgensen this afternoon and thank him for agreeing to voluntarily testify on a solo panel before the HELP Committee on the high cost of Ozempic and Wegovy in the United States," Sanders said in a statement. "The scheduled subpoena vote is no longer necessary and will be cancelled."... Full

Novo Nordisk CEO Agrees to Bernie Sanders' Demand to Testify On Ozempic, Wegovy Prices

(6/14, Rachel Cohrs Zhang, STAT) ...The agreement is a finale to a farcical public back-and-forth over apparent difficulties between the Senate health committee and Novo in scheduling a hearing. Sanders' team claimed that Novo was uncooperative with his requests, but the company said they had told the senator's team that the company was willing to testify. Jørgensen's appearance is a pivot for the panel, as Sanders (I-Vt.) had originally scheduled a vote to subpoena the chief of Novo's U.S. division, Doug Langa, instead. Sanders said that the scheduled subpoena vote, which even Democratic senators wouldn't firmly commit to supporting, has been canceled... Full

It Will Take More Than US Bargaining Power to Cut Drug Costs

(6/17, Damian Garde, Bloomberg) ...Despite those high hopes and dire warnings from the two sides, Uncle Sam's new ability to negotiate drug prices is unlikely to make a meaningful dent in how much Americans pay for their medicines, which is determined by a Rube Goldberg machine of discounts, rebates and middlemen that baffles and sometimes bankrupts consumers... Sub. Req'd

US Drug Negotiations Plan Shifts Focus for Rare Disease Programs

(6/17, Nyah Phengsitthy, Bloomberg Law) ...The rare disease community is pushing for changes in the Inflation Reduction Act's drug price-setting scheme as it leads more drugmakers and investors to reconsider development of drugs to treat small patient populations. Pharmaceutical companies such as Pfizer Inc., Alnylam Pharmaceuticals Inc., Eli Lilly & Co., and Protagonist Therapeutics said they're halting or reshaping research into rare disease or small-molecule drugs out of concern they may not recoup their costs under the Medicare Drug Price Negotiation Program... Full

NCPA Launches PBM Reform Campaign, Joins Petition For SCOTUS To Uphold OK PBM Law

(6/14, Gabrielle Wanneh, InsideHealthPolicy) ...Community pharmacists have launched a national advertising campaign aimed at persuading federal lawmakers to move forward on pharmacy benefit manager reforms and are also pressing the Supreme Court to reverse an appeals court decision that blocked Oklahoma and potentially other states from implementing their own PBM reform laws... Sub. Req'd

Under Pressure to Thwart Pharma Patent Abuse, The PTO Proposes a New Rule. But Will It Fly?

(6/17, Ed Silverman, STAT) ...In a bid to prevent the patent system from being abused, the U.S. Patent and Trademark Office has proposed a new rule designed to stem the use of so-called patent thickets, which are wielded by pharmaceutical companies to delay the arrival of lower-cost generic medicines in the marketplace...Some companies have begun delisting patents, while others have balked at the FTC warnings, prompting the agency to threaten further action. The FTC has also filed documents in lawsuits in which generic companies are defending infringement claims, and the agency has argued that brand-name companies filed improper or inaccurate patents. Last week, Teva Pharmaceutical lost such a lawsuit... Full

Ending 'Product Hopping' and Other Patent Changes Could Save US $3B Over a Decade, CBO Says

(6/14, Nicole DeFeudis, Endpoints News) ...The Affordable Prescriptions for Patients Act of 2023 targets patent thickets and "product hopping," which the Federal Trade Commission describes as a strategy to shift patients to a newer, patent-protected follow-on drug when the original is about to lose exclusivity...If it became law, the CBO estimated the bill would result in $759 million in federal savings over the next five years and just over $3 billion by 2034, according to its estimate published Thursday... Full

Pharma Investing Is All About Service Now. The Patent Cliff Era Is Ending.

(6/14, Molly McGaughan, Barron's) ...For decades, investors have chosen pharma stocks based largely on which companies have drugs and vaccines being sold to large numbers of people. Savvy shareholders in these companies have worked to avoid looming "patent cliffs"—the moments when exclusivity on popular therapies runs out, generics become available, and prices go down. As Barron's noted earlier this year, "Big Pharma is essentially a series of lucrative exclusives balanced by angst over when those monopolies run out."... Full

Federal Support Should Not Be A Factor In Determining Pharmaceutical Prices Under The IRA

(6/14, Frederick McElwee, Amanda Cole, Louis P. Garrison, Jr. And Adrian Towse, Health Affairs) ...One of the information items requested from companies is prior federal financial support for development of the selected drug. We argue that it is difficult to accurately measure the contribution of prior federal funding to a specific product's development, and that, even if this were feasible, this information ought not to be considered under a pharmaceutical innovation reward system that aims to be efficient or "fair."... Full

Drug Enforcement Administration Sends Second Attempt at a Telehealth Prescribing Rule to Executive Budget Office

(6/14, Emma Beavins, Fierce Healthcare) ...The Drug Enforcement Administration's long-awaited second attempt at a telemedicine prescribing rule has been handed off to the Office of Management and Budget for review. The rule is a major issue for telehealth companies that allow for the prescription of controlled substances, such as Adderall for ADHD, testosterone for transgender men, and buprenorphine for opioid use disorder. There is not yet a separate rule for buprenorphine prescribing like there was last March when the DEA attempted its first set of telehealth prescribing rules... Full

OMB Reviews Long-Awaited DEA Rule As Stakeholders Lobby To Ease Telehealth Rx Of Adderall

(6/14, Cara Smith, InsideHealthPolicy) ...The White House budget office on Friday (June 14) began reviewing a long-awaited rule expected to ease telehealth prescribing of controlled substances, days after tele-mental stakeholders stepped up pressure on the Drug Enforcement Administration to include stimulates like Adderall in the rule. But stakeholders face a new hurdle as the rule hit the Office of Management and Budget a day after the Justice Department indicted a key telehealth provider for allegedly overprescribing attention deficit reduction drugs... Sub. Req'd

US FDA User Fee Conundrum: Collections Increase After 25% PDUFA Rate Hike

(6/14, Derrick Gingery, Pink Sheet) ...More than mid-way through fiscal year 2024, the US Food and Drug Administration increased its net collections estimate for the prescription drug user fee program by $30m, or about 2%, "because of the rate of collections thus far this fiscal year," Funmi Ariyo, director of the user fees support staff in the FDA Office of Finance, Budget, Acquisitions and Planning, said during a June 6, agency meeting on user fee program financial transparency and efficiency... Sub. Req'd

32 Bipartisan State Attorneys General Ask Supreme Court to Take Up Oklahoma PBM Case

(6/14, Dave Muoio, Fierce Healthcare) ...In a brief filed this week, 32 of the chief lawyers told the top court that a decision from the U.S. Court of Appeals for the Tenth Circuit handed down last summer has thrown the extent of states' regulatory authority over the intermediaries in question. Oklahoma officials, the case's defendants, filed a petition for the Supreme Court to review the case last month... Full

Colorado PDAB Says Cosentyx Is Unaffordable

(6/14, Luke Zarzecki, InsideHealthPolicy) ...Colorado's Prescription Drug Affordability Board voted that Novartis' Cosentyx is unaffordable for residents of the state Friday (June 14). Cosentyx, used for various forms of psoriasis, arthritis, spondylitis and Hidradenitis Suppurative, is the third drug the board has deemed unaffordable... Sub. Req'd

Novartis' Cosentyx Joins Colorado's List of ‘Unaffordable' Drugs

(6/14, Celine Castronuovo, Bloomberg Law) ...Four members of the Colorado Prescription Drug Affordability Board approved the determination for Cosentyx, the final drug among the five medications for which the board conducted cost reviews. One board member, oncologist Sami Diab, recused himself from the vote due to a conflict. Cosentyx, which is indicated for the treatment of moderate to severe plaque psoriasis and active psoriatic arthritis, cost an average of nearly $47,000 per Colorado patient in 2022, according to the board's draft affordability review report... Sub. Req'd

Colorado Board Decides a Pricey Novartis Medicine is Unaffordable

(6/14, Ed Silverman, STAT Plus) ...In a statement, Novartis said it disagrees with the "claim that Cosentyx is unaffordable, and we remain concerned this decision will limit access for patients facing significant physical and emotional burden from the autoimmune diseases that Cosentyx treats. Novartis is confident in the value of Cosentyx and are committed to providing broad, affordable access for patients that are prescribed it."... Sub. Req'd

B.C.'s Biosimilar Initiative Saves Money, Reinvests to Expand Drug Coverage

(6/14, British Columbia) ...Over the first five years of the initiative, the Province saved $732 million, thanks to people transitioning from reference biologics to their cost-effective biosimilars, which are highly similar versions of high-cost biologic drugs used to treat health concerns, such as diabetes, inflammatory conditions and certain cancers... Full

Policy that Forced Patients to Switch to Cheaper Medications Saved B.C. $730-Million, Report Says

(6/14, Kelly Grant, The Globe and Mail) ...The B.C. government said Friday that the money freed up through its biosimilar switching plan allowed the province to expand public coverage of other drugs and devices, including Trikafta, a life-changing treatment for cystic fibrosis and continuous glucose monitors for people with diabetes... Full

Australia Proposes Clearer Labeling For Injectables To Ensure Safety & Efficacy

(6/14, Ian Schofield, Pink Sheet) ...Australia's Therapeutic Goods Administration is proposing to update its rules on labeling of injectable products that are administered by health professionals in an effort to make the instructions on preparation "clear and consistent."...A four-year transition period was implemented to 2020, since when companies have had to comply with the new requirements. However, the TGA says that some aspects of the new rules need further improvement to ensure injectable medicines are used correctly and safely... Sub. Req'd

Greening India's Industrial Horizon: Navigating Climate Resilience in Pharma and Beyond

(6/15, Hisham Mundol, Express Pharma) ...India's pharmaceutical industry is a global powerhouse. It is already a massive $50 billion market and is projected to grow to $130 billion by 2030. India makes 60 per cent of the world's vaccines and 20 per cent of the world's generic drugs. This shining star does however have two chinks in the armour that industry leaders will be well served to address. One is the need for the sector to invest more in research and development for the innovations that will fuel long-term competitiveness...The second chink is its climate and environmental footprint... Full

Drug Action Network Asks Health Minister to Let Janaushadhi Kendras Dispense Generic Substitutes of Branded Medication

(6/15, Afshan Yasmeen, The Hindu) ...The All India Drug Action Network (AIDAN), involved in advocacy for rational drug policy and use, has urged the Union Health Minister to amend the Schedule ‘H' under the Drugs and Cosmetics Act, 1940, to enable Janaushadhi Kendras to dispense generic substitutes of branded prescription medications... Full

Pharma Industry, Health Advocates Clash Over Jan Aushadhi Prescription Drug Substitution Move

(6/14, PT Jyothi Datta, The Hindu BusinessLine) ...In an open letter to the Union Health Minister, the All India Drug Action Network (Aidan) has opposed a submission from the Indian Pharmaceutical Alliance (IPA), that had said, "If the above recommendation of substituting Schedule H and X drugs is accepted for Jan Aushadhi stores, a similar request may be requested by other trade channel members. This will not be in the interest of patients"... Full

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