Monday, February 12, 2024

  Top News

Piper Sandler Upgrades Teva Pharma (TEVA) to Overweight, 'The Times They Are A-Changin''

(2/12, StreetInsider.com) ...Piper Sandler analyst David Amsellem upgraded Teva Pharma from Neutral to Overweight with a price target of $19.00 (from $12.00). The analyst comments "We are upgrading Teva to Overweight from Neutral and raising our PT to $19 from $12. We have not had a buy recommendation on the shares since 2011, owing to the erosion of Copaxone and Teva leaning in heavily on U.S. generics via the $41B Actavis Generics purchase in 2016 just ahead of what turned out to be a fraught period for the space.”... Full

Well-Positioned Teva Wins Back a Wall Street Bull

(2/12, Dow Jones) ...Piper Sandler upgrades Teva Pharmaceutical to overweight from neutral, marking the firm's first bullish call on the generic drugmaker since 2011. In a research note, Piper says that after the $40 billion buy of Allergan's generic drug business in 2016 that essentially set Teva back a decade, it believes Teva shares are well-positioned for further multiple recovery/expansion... Sub. Req'd

Teva Upgraded to Overweight from Neutral at Piper Sandler

(2/12, The Fly) ...Piper Sandler analyst David Amsellem upgraded Teva Pharmaceutical to Overweight from Neutral with a price target of $19, up from $12. The firm has not had a Buy recommendation on the shares since 2011, owing to the erosion of Copaxone and Teva leaning in heavily on U.S. generics. However, the analyst now believes the shares are well positioned for further multiple expansion... Full

Piper Sandler Upgrades Teva Shares to Overweight, Target Raised to $19

(2/12, Investing.com) ...The analyst also noted that Teva's U.S. generics and biosimilars business is better positioned now, with expectations of at worst, muted pressure. This is a notable shift from the challenges the company faced following its $41 billion acquisition of Actavis Generics in 2016, a move that was deemed to have set Teva back a decade... Full

'We Need Investments and Clear Targets to Maintain Our Competitive Edge' - Roberta Metsola

(2/10, Malta Independent) ...During a visit to Teva Pharmaceuticals Malta in the Bulebel Industrial Estate, President Metsola met with the management and staff who work on Solid Dosage Form Manufacture. President Metsola said that the EU's Single Market is one of our greatest achievements...Teva Malta managing director Patrick Cachia said, "it was an honour and a great opportunity to be able to offer Dr Metsola a firsthand insight" into its operations... Full

Metsola Pushes for More Investment to Help Businesses in Green Transition

(2/10, Times Of Malta) ...The European Union and its member states must set clear targets and incentives if businesses are to invest in the green transition, Roberta Metsola believes. Speaking during a visit to Malta's largest pharmaceutical company, Metsola argued that the European Green Deal is as much about security and ensuring competitiveness as it is about sustainability...During that visit, she met with staff and management of Teva Pharmaceuticals at the Bulebel Industrial Estate. With 514 employees, Teva is the largest company in Malta's pharmaceutical sector... Full

Annual BioNJ Dinner Celebrates Innovation, Life Sciences

(2/9, Matthew Fazelpoor, NJBIZ) ...Insmed chair and CEO William Lewis was presented the Dr. Sol J. Barer Award for Vision, Innovation, and Leadership. "Often described as one of the humblest people in the industry, it is with immense pleasure that I present this year's award to a truly fine human being – an individual who epitomizes vision, innovation, and leadership through tireless advocacy for patients, the health care system, and New Jersey's life sciences ecosystem," said Barer, former chair and CEO, Celegene Corp., and chair of the board at Teva Pharmaceutical Industries, as he presented his namesake award. "Please welcome the BioNJ 2024 Dr. Sol J. Barer Honoree for Vision, Innovation, and Leadership – Will Lewis."... Full

  Industry News

Major Generic Maker Aurobindo Cuts Production at a Key Plant Amid Concerns Over Shortages

(2/9, Ed Silverman, STAT Plus) ...Aurobindo, which is one of the largest generic drug makers, has halted some production at a key facility in India after U.S. inspectors found manufacturing problems, the latest such episode to underscore concerns over both shortages and the quality of medicines produced by some suppliers...The drugmaker added that consultants have already been hired to fix the problems, which were not specified, and hopes to restart production as soon as possible, although no timetable was provided... Sub. Req'd

Aurobindo Pharma Surges 3% as Investors Cheer Strong Q3 Earnings

(2/12, Money Control) ...Aurobindo Pharma's Q3 net profit soared 91 percent on year and revenue jumped 15 percent. Topline growth was aided by strong performance across all segments, including US and Europe formulations business, specialty and injectables, anti retro0viral and active pharmaceutical ingredient business... Full

No 'Constraining Situation' On Generic Vascepa API, Says Strides MD

(2/12, Vibha Ravi, Generics Bulletin) ...Strides Pharma Science founder and managing director Arun Kumar said he does not see a "constraining situation" for supplies of the active pharmaceutical ingredients to manufacture a generic to Amarin's only commercialized product to date Vascepa (icosapent ethyl)...While Amarin has seen declining sales in the region for Vascepa as Hikma, Dr. Reddy's, Teva and others launched generics, losses in market share have been contained by carved-out patented indications and short supply of raw materials... Global Sub. Full

Gedeon Richter Investment In Formycon Opens Up Collaboration Opportunities

(2/12, David Wallace, Generics Bulletin) ...Gedeon Richter has agreed to acquire a stake of just over 9% in Formycon. The deal "opens up the possibility of jointly leveraging long-term strategic opportunities" while providing Formycon with more than €80m to invest in its biosimilar development projects... Global Sub. Full

FY25 to Be Year of Consolidation for Biocon Biologics: CEO Tambe

(2/10, Ayanti Bera, Financial Express) ...Biocon Biologics, a subsidiary of pharma-major Biocon, will focus on consolidating its acquisition of long-time partner Viatris' biosimilars business in the upcoming fiscal year, in an effort to set a stage for its next phase of growth, its CEO and MD Shreehas Tambe told Fe on Friday... Full

New CEO Rises to Challenge as Lundbeck Eyes Competition

(2/12, The Pharma Letter) ...Presenting the CNS specialist's financial results for the first time since his appointment in September, Mr van Zyl has a lot to be cheerful about - with buoyant growth for all key products...As part of a major strategic review, undertaken during his first three months in post, Mr van Zyl highlighted new collaborations and acquisitions as a key area of focus. The company has said that it does not plan a radical overhaul reminiscent of its early days, while stressing that future growth is dependent on investment in innovation - an approach which inevitably means taking risks... Sub. Req'd

Moderna's Stock Slumps After RSV Shot Efficacy Wanes Faster Than GSK's Arexvy

(2/9, Gabrielle Masson, Fierce Biotech) ...The efficacy of Moderna's investigational respiratory syncytial virus (RSV) vaccine appears to wane faster than GSK's approved shot Arexvy, a revelation that sent the Big Biotech's stock slipping. Phase 3 data shared Thursday showed overall efficacy of 63.3% after 8.6 months in preventing RSV-associated respiratory tract disease with two or more symptoms, dropping from 84% at 3.3 months... Full

Who's Hired? Sandoz Freshens Up Directors Board After Pivotal Year

(2/9, Urte Fultinaviciute, Generics Bulletin) ...Sandoz nominated a new director candidate ahead of its annual meeting and Lantheus welcomed a familiar face as the new CEO. Meanwhile, Mallinckrodt strengthened its board with four new directors and Hikma announced another appointment this year... Global Sub. Full

U.S. FDA Issues Inspection Report with VAI to Dr. Reddy's Plant

(2/10, The Hindu) ...A formulations manufacturing facility of Dr. Reddy's Laboratories in Hyderabad, which was issued a Form 483 with ten observations in October by the United States Food and Drug Administration, has received an establishment inspection report with the regulator classifying the inspection as voluntary action indicated... Full

Drug Costs and Nocebo Risks: Navigating the Humira ‘Biosimilar Boom' 1 Year Later

(2/9, Rob Volansky, Healio) ..."We still do not know what impact will occur from so many biosimilars in the market," Vibeke Strand, MD, MACR, FACP, a biopharmaceutical consultant and clinical rheumatologist based in Portola Valley, California, told Healio. According to Strand, most academic centers have been "slow" to include biosimilars in their formularies..."One is the U.S. Veterans Affairs system, which remains largely opaque to us working in their clinics, except to be told which is being used, and the other is the Kaiser Permanente system," she said. As of March 2023, Kaiser uses Inflectra (infliximab-dyyb, Celltrion/Pfizer) for infliximab, Amjevita for adalimumab and Riabni (rituximab-arrx, Amgen) for Rituxan (rituximab, Genentech), according to Strand. She added that Kaiser initially accepted Truxima (rituximab-abbs, Teva)... Full

Analyzing Safety of Switching From Originators to Biosimilars: A Meta-Analysis of 21 Trials

(2/10, Deana Ferreri, PhD, The Center For Biosimilars) ...The authors of a meta-analysis published in PLOS ONE found that serious adverse events, deaths, and treatment discontinuations observed in patients who switched between a biosimilar and reference biologic were similar to those in patients who did not switch. Additionally, adverse events linked to immunogenicity showed no significant differences between switched and non-switched patients across various biologics... Full

  U.S. Policy & Regulatory News

Generics Industry: Congress Needs To Fight Price Deflation

(2/9, Jessica Karins, InsideHealthPolicy) ...Saying their industry is facing unprecedented pricing pressures, manufacturers of generics and biosimilars are pressing Congress to support policies they say would both benefit them and avert future shortages, like acting on pharmacy benefit manager reform and repealing a Medicaid penalty for price increases. At the Association for Accessible Medicines annual meeting in Tampa, FL this week, officials with the generics and biosimilars lobbying group told Inside Health Policy lawmakers striving to address high drug prices should focus on the progress that can be achieved by making it easier for generics and biosimilars to reach the market... Sub. Req'd

PBM Legislation And The Meaning Of ‘Meaningful' Reform

(2/11, Cathy Kelly, Pink Sheet) ...The message from Johnson & Johnson CEO Joaquin Duato, Bristol Myers Squibb Company CEO Chris Boerner and Merck & Co., Inc. CEO Robert Davis seemed to be that "delinking" PBM compensation from list prices would be more effective at addressing PBM activities than transparency requirements. But neither would have as much of an impact as mandating that PBMs and insurers pass rebates through to patients at the point of sale, which is not included in the bills now advancing... Sub. Req'd

Lawmakers Wary Of House Oversight Passage Of PBM Delinking Reform

(2/9, Gabrielle Wanneh, InsideHealthPolicy) ...Republicans and Democrats alike are wary of the impact a bill seeking to reform how pharmacy benefit managers interact with the Federal Employee Health Benefits Program would have on the program that provides coverage for millions of federal workers, even though the House Oversight Committee advanced such legislation on Tuesday (Feb. 6)...Rep. Eric Burlison (R-MO), who is also a member of both the House Oversight and Education & the Workforce committees, voted against the bill. Burlison said that while the DRUG Act's delinking policy sounds good on paper, over the long term it would only raise consumer's premiums and prices... Sub. Req'd

Patient Assistance Programs From Pharma Companies Need Streamlining, US Senators Say

(2/9, Sue Sutter, Pink Sheet) ...BMS CEO Boerner acknowledged the complexity of patient assistance programs, and the need for simplification, during a Senate hearing. CEOs of J&J and Merck also tout their patient assistance programs as showing the firms' commitment to helping patients access drugs they cannot afford. Simplifying patient assistance program applications may be an administrative fix that comes out of the Senate Health, Education, Labor and Pensions Committee's recent hearing on US drug prices... Sub. Req'd

CBO Still Weighing IRA's Effect On Drug Innovation, Economic Outlook Omitted Issue

(2/9, Gabrielle Wanneh, InsideHealthPolicy) ...The Congressional Budget Office is continuing to assess new data on the Inflation Reduction Act's impact on pharmaceutical innovation after its latest 10-year economic outlook looked at projections for the IRA's clean vehicle and energy-related tax credits but not its drug price controls. CBO staff told Inside Drug Pricing the agency continues to receive and evaluate new research on drug innovation and how changes drug companies are expected to see in their future profits due to policies like drug price negotiation in Medicare will affect the development of drugs... Sub. Req'd

As Cancer Drug Shortages Persist, ASCO Official Urges Congressional Action at Hearing

(2/9, Zoey Becker, Fierce Pharma) ...In prepared testimony for a recent House committee hearing on drug shortages, ASCO's chief medical officer, Julie Gralow, M.D., pushed for action in the areas of payment, manufacturing and more...Gralow cited an analysis showing that more than half of the drugs currently in shortage have some of the lowest prices on the U.S. pharmaceutical market. Cheap drugs are often sold at a loss, leaving manufacturers to routinely outsource their operations outside of the U.S. to keep costs down or stop producing the meds entirely. To address this, lawmakers could implement incentives to boost U.S. manufacturing and encourage more advanced technologies such as continuous manufacturing, Gralow said... Full

AAM Annual Meeting: CDER Discusses Biologics and CEOS React

(2/9, Bob Pollock, Lachman Consultants) ...At the recent AAM meeting, Jacqueline Corrigan-Curay, J.D., M.D., Principal Deputy Center Director, CDER, provided an overview of the current state of activities at the Agency regarding biosimilar development and approvals. The FDA has been quite successful in implementing its biosimilar program and has moved the needle on approvals... Full

Doug Long Receives Lifetime Achievement Award at AAM Annual Meeting After Presentation

(2/9, Bob Pollock, Lachman Consultants) ...ADHD medicine use grew 11% over the last five years to over three billion days of therapy in 2022. This demand increase explains in part the shortage of ADHD drugs, especially because there are strict DEA quotas allocated for these drugs, limiting the amount of active pharmaceutical ingredient available for manufacturers...Drug shortages continue and seem to be more difficult to resolve. We all know the factors that have created many of the drug shortages; for instance, compliance and quality issues, supply chain challenges, and increased demand, all of which contribute to the problem. Shortages of critical drugs, like injectable chemotherapy agents, have caused serious problems for treatment of critically ill patients... Full

How Push to Limit Chinese Biotech Could Threaten U.S. Edge

(2/12, Alison Snyder, Axios) ...Bipartisan consensus for action is growing amid deteriorated U.S.-China relations, but it's running into the reality that they'll have to balance moves to address U.S. national security concerns with the risk of setting back companies that underpin the country's competitive edge. The "geopolitics and trade and investment parts of the U.S.-China relationship are on totally different planes," says Scott Michael Moore, director of China Programs and Strategic Initiatives at the University of Pennsylvania... Full

Maryland Lawmakers Explore Options to Cap Prescription Drug Costs

(2/11, Rachel Duncan, WBAL) ...Maryland lawmakers are considering options to try to cap prescription drug costs. The rising costs of prescription drugs is something most people are facing...Lawmakers in Annapolis are considering Senate Bill 388, which could help ease some of the burden. If passed, it would allow the Prescription Drug Affordability Board to cap the costs of certain medications. "A staggering one-in-three Marylanders are reporting they have skipped a dose, rationed medication or left a prescription at the pharmacy counter due to cost," said Anne Arundel County Sen. Dawn Gile, D-District 33, one of the bill's sponsors... Full

  International News

US and EU Regulators Begin Offering Parallel Scientific Advice to Generic Drugmakers

(2/9, Zachary Brennan, Endpoints News) ...The FDA and European Medicines Agency collaborate often and meet regularly, but the two drug regulators have now announced that for the first time, they will begin offering parallel scientific advice for generic drugmakers as part of a pilot project. The parallel advice will begin for complex generic drugs as part of a voluntary pilot project that expands upon FDA and EMA's parallel advice for new drugs and biologics... Full

ABPI Presents Pre-Election Vision For Boosting UK Clinical Trials, Innovation & Manufacturing

(2/9, Francesca Bruce, Pink Sheet) ...Shortly after the UK Labour Party disclosed its plans for boosting the country's life sciences sector, the Association of the British Pharmaceutical Industry published its own proposals outlining what a new government must do to "make the UK the best place in the world to research, develop and use the medicines and vaccines of the future." With a general election expected sometime in the second half of this year, the ABPI has welcomed Labour's life science plan, saying it would "help our industry to deliver the cutting-edge treatments National Health Service patients need and deserve and help the UK to better compete on the global stage."... Sub. Req'd

A Focus On Progress of Pharmaceutical Industry of India

(2/10, Dr. Prashant Prabhakar Deshpande, The Times Of India) ...CRISIL, a global analytical research and rating agency has indicated in its analysis that, sales of India's domestic pharmaceutical sector are expected to grow 8–10 % during the financial year 2023-24. This growth will be driven by consistent domestic expansion and increased exports to the regulated markets, although, semi-regulated markets, i.e., the small and medium scale industries that are not completely governed and regulated by their governments, may face challenges according to the firm, the Regulated markets encompassing regions like the US, Europe, and Canada, while the Semi-regulated markets comprising Asia, Africa, and Latin America... Full

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