Thursday, January 4, 2024

Off-Patent Personnel Moves In 2023 Reflect Growing Interest In Innovator Space

(1/3, Chloe Kent, Generics Bulletin) ...Executive changes at both Viatris and Teva in 2023 saw the companies shift their focus towards the innovator industry....Viatris isn't the only major generics player flirting with brand ambitions, as Teva likewise eyes up the patent-protected market. A strategic review in 2023 prompted the company to reveal a new "pivot to growth" strategy, which will include complex generics, 505(b)(2) products and biosimilars alongside more innovative products, including branded medicines such as Austedo (deutetrabenazine) and Ajovy (fremanezumab)... Global Sub. Full

Piper Sandler Raises Teva to Neutral, Stock Up 4%

(1/3, Val Brickates Kennedy, Seeking Alpha) ...The investment bank added, however, that it couldn't get more constructive on the stock because nearly 25% of Teva's topline was driven by US generics, a lack of visibility into how much new brand assets can spur EBITDA growth, and the "relatively slow pace of improvement in leverage ratios."... Full

CVS Will Remove AbbVie's Humira from Some Drug Reimbursement Lists in April

(1/3, Patrick Wingrove, Reuters) ...CVS Health said on Wednesday it will remove AbbVie's blockbuster rheumatoid arthritis drug Humira from some of its lists of preferred drugs for reimbursement as of April 1, and will recommend biosimilar versions of the medicine instead. CVS said Hyrimoz and an unbranded version of Humira, both from Swiss drugmaker Sandoz, will be covered across all its formularies, while branded and unbranded near copies of the drug from India's Biocon will be covered on some reimbursement lists... Full

Formycon And Alvotech Offer Updates On Aflibercept

(1/3, David Wallace, Generics Bulletin) ...Biosimilar aflibercept rivals to Eylea are advancing towards approval, with Formycon reporting EMA acceptance of its filing for its FYB203 version and Alvotech disclosing positive trial results for its AVT06 candidate. Further progress has been seen for Eylea (aflibercept) biosimilars in recent days, after Formycon revealed that a European filing for its FYB203 candidate had been accepted for review by the European Medicines Agency, shortly before Alvotech unveiled positive trial results from a confirmatory clinical study for its AVT06 proposed biosimilar... Global Sub. Full

AstraZeneca Sues Samsung Biologics to Block Soliris Biosimilar

(1/3, Christopher Yasiejko, Bloomberg Law) ...Alexion Pharmaceuticals Inc. filed its first lawsuit seeking to block a biosimilar version of its blockbuster Soliris, alleging a Samsung Biologics Co. subsidiary infringes six patents for the AstraZeneca Plc unit's half-million-dollar-per-patient treatment... Sub. Req'd

Roche Designs New Antibiotic to Fight Deadly A. Baumannii Infections

(1/3, Helen Floersh, Fierce Biotech) ...In a pair of articles published Jan. 3 in Nature, Roche and Harvard University scientists described how they developed a new antibiotic that is effective against carbapenem-resistant acinetobacter baumannii—also known as CRAB—in mice. The drug, zosurabalpin, works by interrupting construction of the bacteria's outer membrane... Full

Dr. Reddy's, Torrent Pharma and Laurus Synthesis All Land Form 483 Letters Following FDA Inspections

(1/3, Anna Brown, Endpoints News) ...In December the FDA hit India-based Torrent Pharmaceuticals, Laurus Synthesis and Dr. Reddy's Laboratories each with Form 483 letters published on Dec. 28. This was Dr. Reddy's second letter in just two months. In the latest 12-page letter for Dr. Reddy's site located at Telangana, India, the FDA noted in detail three observations found between Dec. 4 and Dec. 8. The first Form 483 for the generic drug giant followed an inspection in October for a different unit... Full

Smokers Taking Old Generic Drug Are Twice as Likely to Quit

(1/3, Elina Ganatra, Bloomberg) ...Scientists found that the treatment was twice as effective as a placebo — and marginally better than nicotine substitutes — in research published earlier this week in the medical journal Addiction. The findings come as the drug becomes available in the UK almost five years after its regulatory clearance. Consilient Health, an Irish drugmaker, plans to start selling it Jan. 22... Full

Cigna Nears Deal to Offload Medicare Business

(1/3, Laura Cooper, Anna Wilde Mathews and Lauren Thomas, The Wall Street Journal) ...Cigna, which has been running an auction for the business, known as Medicare Advantage, is now in exclusive talks to sell it to Health Care Service Corp. for between $3 billion and $4 billion, according to people familiar with the matter...Cigna is proceeding with the potential sale even though its talks to acquire Medicare-focused insurer Humana broke off after investors reacted coolly to the possible megadeal. Cigna said that it plans an additional $10 billion of stock buybacks. It is also expected to focus on smaller, so-called bolt-on acquisitions... Sub. Req'd

Tales of the Unsurprised: U.S. Brand-Name Drug Prices Fell for an Unprecedented Sixth Consecutive Year (And Will Fall Further in 2024)

(1/3, Adam J. Fein, Ph.D., Drug Channels) ...For 2023, brand-name drugs' list prices again grew at mid-single-digit rates. However, net prices dropped for an unprecedented sixth consecutive year. What's more, after adjusting for overall inflation, brand-name drug net prices plunged by more than 7%...Employers, health plans, and PBMs determine whether patients share in this ongoing deflation. Meanwhile, these data challenge drug pricing flat earthers who remain committed to a false narrative of "skyrocketing" drug prices. As I discuss below, manufacturers will face ongoing pressure on net prices from both commercial and government payers. They will also have new incentives to limit growth in list prices—and will even reduce list prices on certain drugs (as some are already doing)... Full

Burning Questions for the 2024 JPM Healthcare Conference

(1/4, Damian Garde , Adam Feuerstein , Allison DeAngelis , Matthew Herper , and Mohana Ravindranath, STAT Plus) ...J.P. Morgan week, which brings some 20,000 industry professionals to crowd the streets of Union Square, will be a timely barometer of whether all that newfound optimism will carry through into 2024. Here's our list of the burning questions facing the health care industry as it climbs out of a downturn and looks ahead to a long-awaited rebound... Sub. Req'd

Circuit Courts, State Laws to Test Drug Discount Program in 2024

(1/4, Nyah Phengsitthy, Bloomberg Law) ...Drugmakers in recent years have limited dispensing discounted drugs to hospitals and certain pharmacies alleging practices that don't benefit patients, but covered entities argue the opposite and say the savings are used for extended care. The differences have spurred lawsuits that will continue in the new year. The 340B program sits in a vulnerable place as pending court cases and administrative rules in 2024 could critically change the program's operations and who benefits from it. More than 2,600 US hospitals—over a third of them—participate in the 340B program, according to a report from the US Government Accountability Office... Full

Biden Administration to Use Defense Production Act to Tackle Drug Shortages

(1/3, Lia DeGroot, Endpoints News) ...President Joe Biden is directing HHS to use the Defense Production Act to boost the production of drugs in shortage, he wrote in a memo to the agency last week...The FDA this past fall worked with manufacturers to boost production of the cancer drugs cisplatin, carboplatin and methotrexate. The White House is also working with Sanofi and AstraZeneca to increase availability of their RSV monoclonal antibody, which drew more demand this season than the manufacturers had planned to meet... Full

Time for New Ideas to Address Rising Drug Shortages

(1/3, Kevin B. O'Reilly, AMA) ...Aimed at combating these drug shortages, the policy was informed by an AMA Council on Science and Public Health report that examined three root causes for drug shortages: the evolving prescribing landscape, modern challenges of advertising and patient demand, and the economics and fragility of generic drug manufacturing. The report also noted that drug shortages can be the result of factors such as decades-long policy choices causing a decline in domestic manufacturing, production quotas, and severe weather...The report outlines potential solutions, including exploring nonprofit or government-owned generic drug manufacturing... Full

Opinion: To Prevent Drug Shortages, Protect Generic Drug Manufacturers

(1/3, Ted Love, Newton Daily News) ...With Medicare imposing price controls on brand-name drugs that are still protected by patents, the government is effectively capturing much of the spread between the production cost and the market price. So suddenly, the incentive for a generic company to enter the marketplace is gone. The point here is two-fold. Before the dramatic rise of the buying power of PBMs, drug shortages were fewer because enough generic manufacturers could stay profitable to overcome disruptions on the supply or demand side. That's no longer true... Full

Lawmakers Ask HHS to Drop Copay Assistance Court Challenge

(1/3, Sara Hansard, Bloomberg Law) ...The 19 senators, led by Roger Marshall (R-Kan.) and Tim Kaine (D-Va.), applauded a recent decision by a D.C. federal court in a letter to the heads of HHS and the Treasury and Labor departments released Tuesday...Patient groups, including the HIV and Hepatitis Policy Institute, oppose the use of copay accumulator adjustment programs that limit the amount of assistance patients can receive from drug manufacturers under insurance cost-sharing rules. The groups argue that copay assistance helps people afford their drugs... Full

Biopharma's Prospects Under A Second Trump Term: They Can't Get Much Worse

(1/3, Cathy Kelly, Pink Sheet) ...The biopharma industry may have opportunities to alleviate some aspects of the Biden Administration's policies on drug pricing reform if former president Donald Trump is re-elected in 2024, but it won't be easy, according to former Trump advisor Joe Grogan...The Biden Administration has managed to implement a suite of government price controls on drugs that have long been sought by Democrats and the number and scope of the policies have caught the industry by surprise, Grogan noted in an interview with the Pink Sheet... Sub. Req'd

US FDA Considers Making More Guidance Final Without Public Comment

(1/3, Derrick Gingery, Pink Sheet) ...Sponsors and stakeholders soon could see more new US Food and Drug Administration guidances that skip the public comment process prior to their finalization in an effort to speed publication of agency thinking. Many guidances are issued in draft form at first. After a public comment period, the agency reviews the responses and makes changes before issuing a final guidance that represents its up-to-date thinking... Sub. Req'd

FDA Guidance On AMTs Emphasizes Benefits For Participants

(1/3, Jessica Karins, InsideHealthPolicy) ...Drug makers that use advanced manufacturing technologies (AMTs) can expect benefits from FDA, including early interaction with agency officials and expedited reviews of their applications, the agency stresses in a guidance released before Christmas. The guidance lays out how FDA will designate methods or combinations of methods for manufacturing a drug as AMTs under a new program that the agency hopes will not only improve drug quality but also increase the supply of critical drugs, helping avoid drug shortages... Sub. Req'd

Real-World Data: FDA Expounds On Use Of Registries, Challenges In Standardization

(1/3, Brenda Sandburg, Pink Sheet) ...The US Food and Drug Administration closed out the year with the issuance of two final guidances on the use of real-world data, both of which provide minor changes to draft guidances issued in the fall of 2021. The final guidance entitled "Real-World Data: Assessing Registries to Support Regulatory Decision-Making for Drug and Biological Products," specifies what sponsors should consider in designing a registry or proposing to use an existing registry to support a regulatory decision about a drug's effectiveness or safety... Sub. Req'd

The Path Ahead: Medicines For Europe Head Highlights Opportunities And Risks

(1/3, David Wallace, Generics Bulletin) ...In the third and final part of an exclusive three-part interview with Generics Bulletin, Medicines for Europe director general Adrian van den Hoven looks to the opportunities ahead for value added medicines and biosimilars in Europe, as well as the potential solutions to the pressures facing small-molecule generics... Global Sub. Full

Drug Pricing Watchdog Fixes Retail Rates for 19 Formulations, Including Cancer Pills

(1/4, Neethi Rojan, Money Control) ...The National Pharmaceutical Pricing Authority (NPPA) has fixed the retail price of 19 formulations, including a cancer drug and a medicine for the treatment of hypertension through a January 3 notification... Full

Brazilian Regulator OKs ‘Skinny Labeling' But Legal Situation Remains Unclear

(1/3, Ian Schofield, Pink Sheet) ...A new rule allowing generics firms to "carve out" patented indications from their labeling to avoid possible patent infringement is due to come into effect on February 6, after it was approved last month by the Brazilian drugs regulator, Anvisa...The amendment to Rule No 47/2009 approved by Anvisa would remove the current prohibition on so-called "skinny labels" with the aim of increasing access to cheaper generic versions of originator products. The move comes after a public consultation run by Anvisa from December 2022 to April 2023... Sub. Req'd

Strong Performance in US Market to Support Indian Pharma's Growth in FY2024: ICRA

(1/4, Express Pharma) ...ICRA expects the revenues of a sample set of 25 Indian pharma companies (which account for ~60 per cent of the overall revenues of the Indian pharma industry) to expand by 9-11 per cent in FY2024, post a YoY growth of 10 per cent in FY2023...Commenting on the product shortages and increasing regulatory risks in the US market, Deepak Jotwani, Assistant VP & Sector Head, ICRA, said, "Apart from some key drugs going off-patent, product shortages in select therapeutic segments (oncology, pain/anesthesia, cardiovascular among others) in the recent quarters have also been a growth driver for generic companies in the US market to some extent”... Full

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