Thursday, June 27, 2024

Teva Exec Reveals the AI Tools Pharma Really Wants

(6/26, Gali Weinreb, Globes) ...At the 22nd BIOMED Israel Conference and Exhibition, held about a month ago in Tel Aviv, Dr. Eric A. Hughes, executive VP of global R&D and chief medical officer at Teva Pharmaceutical Industries, revealed not only his dream for implementing AI at the company, but also what Teva is already doing in practice today with these capabilities...As a pioneering company in treating movement disorders, Teva is today highly interested in measuring biomechanics using wearable products, says Hughes... Full

Teva Price Target Raised to $23 from $19 at Jefferies

(6/27, The Fly) ...Jefferies raised the firm's price target on Teva to $23 from $19 and keeps a Buy rating on the shares. Despite strong performance year-to-date, Jefferies sees further upside from here given Teva's current valuation does not reflect strength of key products, biosimilar approvals and progress on the innovative pipeline, the analyst tells investors in a research note... Full

Drugmaker Servier Loses EU Court Fight Over Pay-For-Delay Deals

(6/27, Foo Yun Chee, Reuters) ...French drugmaker Servier on Thursday lost its court battle against a European Union fine for deals with rivals to delay sales of generic copies of its top-selling blood pressure medicine perindopril. The European Commission fined Servier 331 million euros ($354 million) in 2014 - and also fined generic drugmakers Teva, Unichem and its subsidiary Niche, Matrix which is now known as Mylan Laboratories, Krka and Lupin - for their so-called "pay-for-delay" deals between 2005 and 2007... Full

Teva Pays $750M to Resolve Israeli Tax Issues Going Back More Than a Decade

(6/26, Tristan Manalac, BioSpace) ...With Tuesday's resolution of its tax litigation, Teva can now focus on its "Pivot to Growth" strategy, which CEO Richard Francis unveiled in May 2023. The strategy is designed to help Teva regain its footing in the industry and plot its path toward short- and long-term growth after years of declining sales... Full

US Cancer Centers Warn Drug Shortages Continue, Impacting Different Varieties of Medications

(6/26, Jacqueline Howard, CNN) ...Among 28 large cancer centers across the country, 89% reported last month that at least one drug used to either treat cancer, its symptoms or the side effects of treatment was in short supply at their center, according to new survey results released Wednesday by the National Comprehensive Cancer Network...The new survey also indicated that the current shortage of cancer drugs has not significantly disrupted patient care or clinical trials. But additional administrative work has been needed to ensure these things are not disrupted, according to NCCN... Full

Cancer Drug Shortages Continue in the US, Survey Finds

(6/27, Megan Brooks, Medscape) ..."Many drugs that are currently in shortage form the backbones of effective multiagent regimens across both curative and palliative treatment settings," NCCN's CEO Crystal S. Denlinger, MD, told Medscape Medical News..."Thankfully, the shortages for carboplatin and cisplatin are mostly resolved at this time," Denlinger said. However, all three NCCN surveys conducted in the past year, including the most recent one, have found shortages of various chemotherapies and supportive care medications, which suggests this is an ongoing issue affecting a significant spectrum of generic drugs... Full

After Stock Crash and Staff Cuts, Amarin Wins Bid to Revive Vascepa Patent Lawsuit

(6/26, Fraiser Kansteiner, Fierce Pharma) ...Tuesday, the U.S. Court of Appeals for the Federal Circuit revived Amarin's Vascepa patent lawsuit against generics giant Hikma. "Because Amarin's allegations against Hikma plausibly state a claim for induced infringement, we reverse," the court wrote in a legal filing this week. The case comes down to so-called "skinny labels," which allow generic drug makers to get their copycat medicines approved for one or several—but not necessarily all—approved indications of their brand-name counterparts. The practice has proven controversial in Amarin and Hikma's case, plus at least one other lawsuit involving Teva and GSK... Full

AI-Focused Formation Secures Sanofi-Backed $372M Series D to License More Drugs

(6/26, James Waldron, Fierce Biotech) ...Megarounds have been few and far between in 2024, but Formation Bio has managed to draw in an impressive $372 million series D as the AI-focused biotech seeks to expand its pipeline...The idea is that Formation will partner with biotechs to improve their workflow automation—such as generating tailored patient recruitment content for specific cohorts of a clinical trial or speedily producing AI-generated adverse event reports...Sanofi already announced a drug development partnership with both Formation and OpenAI last month. CEO Paul Hudson used a statement in this morning's release to reemphasize that the French pharma is "all in on AI."... Full

AbbVie and Genmab Score Accelerated Follicular Lymphoma Nod for Epkinly 

(6/27, Nicole DeFeudis, Endpoints News) ...AbbVie and Genmab are celebrating their second accelerated approval for Epkinly, this time in follicular lymphoma. The bispecific antibody, also known as epcoritamab, was approved on Wednesday for relapsed or refractory follicular lymphoma patients who've received at least two prior therapies. Follicular lymphoma is a common, slow-growing form of non-Hodgkin's lymphoma, accounting for 10% to 20% of "all lymphomas in the western world," according to AbbVie and Genmab... Full

With FDA Nod, Verona's Ohtuvayre is Set to Jack Up the COPD Market

(6/26, Kevin Dunleavy, Fierce Pharma) ...Ohtuvayre becomes the first novel treatment advance in more than a decade for COPD, an inflammatory condition which restricts airflow from the lungs and leaves patients struggling to breathe. Ohtuvayre is approved as an add-on medicine with current therapies..."It's really the first novel mechanism as an inhaled therapy in over 20 years for COPD," David Zaccardelli, Verona's CEO said in an interview with Fierce Pharma...Verona plans to launch Ohtuvayre in the third quarter of this year... Full

Samsung Bioepis to Launch Stelara Biosimilar 40% Cheaper Than Original

(6/27, Lee Han-soo, Korea Biomedical Review) ...Samsung Bioepis announced its plans to launch Epyztek (ingredient: ustekinumab), a biosimilar product referencing Janssen's Stelara, in July. Epyztek will be priced 40 percent cheaper than the original. According to the Health Insurance Review and Assessment Service's notice on Wednesday, Epyztek's price will be at 1,298,290 won ($936) for a 45mg/0.5ml pre-filled syringe from July, which is approximately 40 percent less than the original drug (2,182,000 won)... Full

Moderna Says its RSV Shot is 50% Effective Across a Second Season

(6/26, Michael Erman, Reuters) ...Moderna Inc respiratory syncytial virus shot mRESVIA showed 50% efficacy in preventing RSV after 18 months, the drugmaker said on Wednesday. In their clinical trials, GSK's RSV vaccine Arexvy was 78% effective in preventing severe RSV over a second year and Pfizer's was 78% effective through a second RSV season... Full

CDC Immunization Advisers Vote to Shrink Recommendations for RSV Vaccination

(6/26, Zoey Becker, Fierce Pharma) ...In an unconventional move, the CDC's Advisory Committee on Immunization Practices revised recommendations for RSV vaccinations in what could be viewed as a smaller population. For what will be only the second RSV season with available vaccines, the panel unanimously voted to recommend that adults aged 75 years and older and those aged 60 to 74 with a higher risk of severe disease due to underlying medical conditions receive a single lifetime dose... Full

Aurobindo Pharma's Telangana unit classified as Voluntary Action Indicated by USFDA

(6/27, CNBC TV 18) ...Aurobindo Pharma Ltd announced on Thursday that it has received an ‘Establishment Inspection Report' from the United States Food and Drug Administration following an inspection conducted in February 2024...The pharma company has informed the stock exchanges on June 27 that the Eugia SEZ injectable facility has now received an EIR, which classifies the facility as Voluntary Action Indicated... Full

Optum Rx May Enter Biosimilar Market to Match Competitors CVS, Express Scripts

(6/26, Katherine Lewin, Endpoints News) ...Top PBM Optum Rx may be moving into the biosimilar business, joining its competitors CVS and Express Scripts, according to a US trademark application for a business called Nuvaila...Ge Bai, a professor of health policy and management at the Johns Hopkins Bloomberg School of Public Health, told Endpoints that now that major PBMs have entered the market, competition will bring pricing pressure to manufacturers. "Biosimilar manufacturers will have a harder time gaining market share when competing with the gatekeeper's own products," Bai said... Full

GoodRx Launches New "Prescription Cost Tracker" to Spotlight Key Factors Driving Out-of-Pocket Medication Costs in the U.S.

(6/26, GoodRx) ...Today, GoodRx, the leading prescription savings platform in the U.S., debuted its new Prescription Cost Tracker where it will monitor out-of-pocket prescription spending trends in the U.S. to help Americans better understand prescription affordability and price transparency... Full

Biden Administration to Lower Costs for 64 Drugs Through Inflation Penalties On Drugmakers

(6/26, Annika Kim Constantino, CNBC) ...The Biden administration on Wednesday said it will impose inflation penalties on 64 prescription drugs for the third quarter of this year, lowering costs for certain older Americans enrolled in Medicare...The list includes Bristol Myers Squibb's Abecma, a cell therapy for multiple myeloma; and Pfizer's targeted cancer treatment for certain lymphomas called Adectris. It also includes Astellas Pharma and Pfizer's Padcev, a targeted cancer treatment for advanced bladder cancer... Full

HHS Lowers 64 Prescription Drug Prices Under Medicare Rebate Program

(6/26, Noah Tong, Fierce Healthcare) ...The latest round of drugs discounted for seniors under provisions of the Inflation Reduction Act treat conditions like osteoporosis, cancer and infections, according to a news release. More than 750,000 Medicare enrollees could save as much as $4,593 per day...Out-of-pocket prescription drug costs will be capped at $2,000 starting in 2025 due to the incremental implementation of the IRA... Full

One More Time: Preparing for Another Round of Drug Price Negotiation

(6/26, Teddy Landsman, Malin Ortenblad and Andrew Frucht, IQVIA) ...As the complex process of price negotiation unfolds, stakeholders will need to leverage modeling and scenario planning to determine the impact this new policy may have - directly or indirectly...While the exact outcomes for industry stakeholders are still uncertain, the impact of price negotiation on and beyond Medicare drugs is all but guaranteed... Full

Tanden: HHS ‘Closely Monitoring' Potential Part D Premium Hikes

(6/26, Sigi Ris, InsideHealthPolicy) ...HHS is working to address potential increases in Part D premiums due to the $2,000 cap on out-of-pocket spending set to go into effect in 2025, Biden administration domestic policy advisor Neera Tanden said Wednesday. Tanden's comments come a day after the drug lobby released an analysis that found 3.5 million seniors could see higher out-of-pocket costs since the Inflation Reduction Act requires Part D plans to set fixed co-pays instead of coinsurance... Sub. Req'd

Wyden Blasts Express Scripts' Pricing Tactics, Asks CMS to Intervene

(6/26, Noah Tong, Fierce Healthcare) ...A leading Democrat and health legislator is urging the Centers for Medicare & Medicaid Services to better enforce Medicare Part D program requirements for pharmacy benefit managers. By evading such requirements, PBMs are threatening the financial health of the country's smaller pharmacies, Senate Finance Committee Chair Ron Wyden, D-Oregon, wrote to the agency in a letter... Full

Trump's Debate Chance O Drug Prices

(6/26, Grace-Marie Turner, The Wall Street Journal) ...As president, Donald Trump focused intensely on lowering prescription drug prices, including a proposal for European-style price controls. Thursday's debate provides him a chance for a fresh approach that builds on his strengths... Sub. Req'd

Blog: Bill Addressing Drug Shortages Provides Long Overdue Relief from Penalties Hurting Generic Drug Market

(6/26, AAM) ...The Association for Accessible Medicines, the leading trade association for generic and biosimilar manufacturers, today released a blog highlighting legislation currently being considered in the Senate Finance Committee that will correct an unintended consequence negatively impacting the generic drugs market and patient access to more affordable medicines... Full

First Look: PhRMA's Ad Campaign to Protect IP

(6/26, Peter Sullivan, Axios) ...PhRMA today is launching a new seven-figure ad campaign defending the drug patent system as Congress ratchets up scrutiny of IP protections, the group tells Axios...The move highlights the growing threats the big industry group sees in patent reform legislation that could be part of a year-end health deal, and in the Biden administration's increased openness to consider using march-in rights to break patents unilaterally...The effort is meant to counter "misinformation" spread by the industry's critics, Robert Zirkelbach, chief public affairs officer at PhRMA, told Axios... Sub. Req'd

PhRMA Launches Education Campaign On the Benefits of America's IP System

(6/26, Robert Zirkelbach, PhRMA) ...There is broad bipartisan support for IP protections, but some policymakers and influencers seem to have forgotten about the full lifecycle of a medicine. There is a misguided focus in Congress and the administration on policies that would weaken IP rights in the name of lowering drug prices. But as the new campaign spotlights, the IP system is actually the vehicle for lower costs. No company or individual has a monopoly on treating a condition. Medicines often face immediate competition from other brand medicines and eventually from generics and biosimilars. In fact, 90% of all medicines dispensed at the pharmacy counter are generics and biosimilars. Generics cost 80% less on average than name-brand alternatives, with an average copay of just $6... Full

Biosimilars Council Submits Comments to FDA for Promotional Labeling and Advertising Considerations

(6/26, Biosimilars Council) ..."The Biosimilars Council applauds the FDA's continued commitment to combatting misinformation about biosimilars, and we strongly support the revised Draft Guidance," said David Gaugh, Interim President & CEO for AAM. "Misinformation has been a significant impediment to use of safe and effective lower priced biosimilars, and the revised guidance will help ensure that sponsors engage in truthful and non-misleading communications regarding biosimilars, including interchangeable biosimilars and their reference products."... Full

3Axis Report Scrutinizes PBM Spread Pricing Practice

(6/26, Denise Myshko, Formulary Watch) ...On the heels of the New York Times investigation of pharmacy benefit managers, a new report finds that PBMs have erratic pricing practices...PCMA, however, questions whether 3Axis Advisors understands pharmacy reimbursement in Washington state. Greg Lopes, vice president of public affairs and communications at PCMA, told Formulary Watch: "The report, like all their others, is just more of the same cherry-picked data that 3Axis attempts to portray as indicative of the entire prescription drug market. 3Axis' founders are affiliated pharmacy lobbyists with an agenda. The report should not be taken seriously."... Full

Get The Facts: WSJ's PBM Article Relied On Deeply Flawed Research—In Reality, PBMs Save Patients Billions

(6/26, PCMA) ...As with all 3 Axis Advisors (46brooklyn) reports, the information used is cherry-picked to confirm their biases and advance a predetermined conclusion. In fact, the founders of 3 Axis Advisors / 46brooklyn are affiliated with the Ohio Pharmacists Association. The work of PBMs leads to an average of $1,040 in savings per covered patient annually. A fact sheet prepared by the Pharmaceutical Care Management Association (PCMA) sheds light on the flawed approach taken by 3 Axis Advisors... Full

Why Washingtonians' RX Prices Are Surging

(6/26, Maddie White, King 5) ...Many frustrated pharmacists in Washington are feeling validated this week after a new analysis proves the industry's third-party drug negotiators are ripping off employer healthcare plans...Historically, PBMs played a vital role in negotiating claims between a pharmacy and an insurance carrier. But now, the new study shows that in many cases, PBMs are marking up medications, including generic ones, like medications for treating HIV. According to the report, PBM-affiliated mail-order pharmacies' drug markups are more than three times the markups at local brick-and-mortar pharmacies... Full

Pharma Industry Has Some Explaining to Do in Minnesota Over 10 Costly Drug Classes

(6/26, Jeremy Olson, Star Tribune) ...The Minnesota Department of Health on Wednesday released its first-ever list of drugs of "substantial public interest," a unique effort among the states to expose the reasons certain prescription prices are marked up..."This is a strong first step toward pulling back the curtain to show the cost drivers that make up prescription drug prices in Minnesota," said Dr. Brooke Cunningham, state health commissioner... Full

The View From The Top: European CEOs Highlight Industry Priorities

(6/27, David Wallace, Generics Bulletin) ...At a high-profile panel closing out Medicines for Europe's 30th annual conference in Dublin, six industry leaders set out their views on key topics including pricing, regulation, sustainability, and stakeholder communication... Global Sub. Full

Latest EU Pharma Reform Proposals Risk Stifling Innovation & Competitiveness

(6/26, Ian Schofield, Pink Sheet) ...EU policymakers have the chance to adopt legislation that establishes a strong and predictable framework of incentives for R&D into new medicines, particularly those that require riskier investments, says CSL Behring's Lutz Bonacker......"As currently proposed, I think there's a risk that Europe will become less attractive and less competitive in the years to come, particularly in a sector like biotechnology which is really critical for us," Bonacker told the Pink Sheet in an interview... Sub. Req'd

Joint Clinical Assessments: How The EMA Will Work With EU Member States On Information Exchange

(6/26, Francesca Bruce, Pink Sheet) ...The European Commission is consulting on the next implementing act in preparation for the forthcoming EU-level joint clinical assessments (JCAs) introduced under the 2022 Health Technology Assessment Regulation. This draft act focuses on information exchange with the European Medicines Agency and is the third of six that will be the subject of a consultation before the JCAs go live in January next year... Sub. Req'd

EMA Calls for Member States to Lend a Hand to Ease GLP-1 Supply Bottlenecks

(6/26, Anna Brown, Endpoints News) ...The ongoing shortage for GLP-1 drugs is unlikely to abate this year, EMA Executive Director Emer Cooke said during a media call Wednesday. As such, the agency established a set of recommendations that could help address bottlenecks. "Shortages of these medicines are a major public health concern and they require urgent and coordinated action across the member states and also across many actors," Cooke added. Eli Lilly and Novo Nordisk have faced supply constraints of their GLP-1 drugs, with three doses of Lilly's diabetes drug Ozempic in limited supply in Europe. Cooke said Lilly's Trulicity, as well as Novo's Victoza and Saxenda, are at risk of shortage... Full

EU Actions to Tackle Shortages of GLP-1 Receptor Agonists

(6/26, European Medicines Agency) ...EMA and the Heads of Medicines Agencies, through the Executive Steering Group on Shortages and Safety of Medicinal Products, have issued recommendations to tackle shortages of the glucagon-like peptide-1 (GLP-1) receptor agonists Ozempic (semaglutide), Saxenda (liraglutide), Trulicity (dulaglutide) and Victoza (liraglutide)...In order to gain a comprehensive overview of the situation, discuss and identify possible additional solutions, the MSSG is organising a multistakeholder workshop on July 1, 2024... Full

Biosimilar Adoption in the UK: Patient and Consultant Views on Safety and Switching

(6/26, Skylar Jeremias, The Center For Biosimilars) ...Key findings showed that there continues to be a lack of understanding and/or confidence in biosimilars among providers and patients, leading to diminished provider willingness to prescribe biosimilars and patient perceptions about the safety of switching to a biosimilar. The UK-based study, published in Pharmacy, aimed to describe the opinions of patients undergoing treatment with originator biologics and medical consultants managing their conditions and identify barriers and enablers to switching to a biosimilar... Full

Riding GLP-1 Wave, China Set to Lead the Charge in Peptide Industry Growth

(6/26, Hu Xiangyun, KrASIA) ... According to the US Securities and Exchange Commission documents, generic drug giants such as Teva, Mylan, and Sandoz have been approved to launch liraglutide generic drugs this year. Although relevant companies have not directly disclosed upstream suppliers, 36Kr reported that Chinese companies have evidently participated in the competition... Full

Indian Pharma Sites Outpace Global Standards in USFDA Inspections for 2023

(6/27, Rimjhim Singh, Business Standard) ...According to a report by the Indian Pharmaceutical Alliance and McKinsey & Company, the United States Food and Drug Administration categorised 13 per cent (19 out of 145 inspections) of Indian facilities as ‘Official Action Indication', which is lower than the global average of 15 per cent OAIs, as reported by The Economic Times. The USFDA conducted inspections of 906 facilities worldwide, resulting in 133 facilities being classified as OAIs... Full

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