Tuesday, January 23, 2024

Jefferies Upgrades Teva Pharma (TEVA) to Buy, 'Expect Trends to Drive Better Guide + Biosim Call Options'

(1/23, StreetInsider.com) ...Jefferies analyst Glen Santangelo upgraded Teva Pharma from Hold to Buy with a price target of $14.00 (from $10.00)...”Overall, we believe as Teva executes on the growth strategy and transitions to innovation focused co, we expect to see multiple expansion this year assuming 1) a strong guide, 2) cont strength in fundamentals 3) biosim approvals and 3) pos pipeline updates in 2H24. Our $14 PT is based on 7x C25E EBITDA."... Sub. Req'd

Teva Upgraded to Buy from Hold at Jefferies

(1/23, The Fly) ...The analyst is bullish heading into the company's 2024 guidance, saying consensus revenue estimates look conservative "despite several tailwinds at play." The firm believes Teva will execute on its growth strategy and transitions to innovation focused company. It expect to sees multiple expansion this year assuming a strong guidance, continued strength in fundamentals, biosimilar approvals and positive pipeline updates in the second half of the year... Full

Corcept Therapeutics Price Target Lowered to $23 from $27 at Leerink

(1/23, The Fly) ...The firm has revised its Corcept financial model to account for recent news that drove volatility in the stock, including the disappointing court ruling on litigation with Teva for Korlym, which Leerink thinks enables generic entry that would cut into Corcept's overall commercial Cushing's syndrome franchise, which was somewhat offset by management's pre-announced FY23 financials and FY24 total revenue guidance, that came in higher than its/consensus estimates... Full

Catalyst Pharmaceuticals At A Crossroads: Firdapse Litigation And Agamree's Launch

(1/22, Myriam Alvarez, Seeking Alpha) ...Firdapse's ongoing IP legal battle with TEVA is key, as a generic competitor should significantly hurt CPRX's long-term prospects. Both of these issues could be positive catalysts if they resolve favorably for the company...In fact, if Firdapse's patent holds against TEVA, the additional upside of the dose increase is pending FDA approval. However, if Agamree disappoints and CPRX's Firdapse patent fails against TEVA's generic drug, it'd be a devastating blow to the company's outlook... Full

Sandoz Plugs Ophthalmology Gap With Coherus Ranibizumab Deal

(1/22, Dean Rudge, Generics Bulletin) ...Sandoz is set to fill a major gap in its blossoming biosimilars portfolio and bolster its ophthalmology offering by acquiring Coherus BioSciences' Formycon-partnered Cimerli (ranibizumab-eqrn) biosimilar to Genentech's Lucentis in the US for $170m upfront, plus inventory costs. The deal, which boosts Sandoz as it anticipates filings for a biosimilar to the cornerstone anti-VEGF eye-disease biologic Eylea (aflibercept), comprises the Cimerli biologics license application, product inventory, ophthalmology sales and field reimbursement talent, as well as access to proprietary commercial software... Global Sub. Full

Asthma Rescue Medication Airsupra is Now Available

(1/22, Formulary Watch) ...AstraZeneca has launched Airsupra (albuterol/budesonide) as an as-needed treatment to reduce the risk of exacerbations in people with asthma aged 18 years and older. Airsupra is a first-in-class, pressurized metered-dose inhaler combination rescue medication containing albuterol, a short-acting beta2-agonist, and budesonide, an anti-inflammatory inhaled corticosteroid. It was developed by AstraZeneca and Avillion... Full

ANI Pharmaceuticals Announces the Launch of Pentoxifylline Extended-Release Tablets, USP

(1/23, ANI Pharmaceuticals Inc.) ...ANI Pharmaceuticals, Inc. today announced the launch of Pentoxifylline Extended-Release Tablets, USP 400mg. ANI's Pentoxifylline ER Tablets are the generic version of the Reference Listed Drug Trental®. The current annual U.S. market for Pentoxifylline ER Tablets is approximately $19.7 million, according to latest estimates from IQVIA/IMS Health, a leading healthcare data and analytics provider... Full

Despite Form 483 from FDA, Alvotech says it's in Position to Win 2 Key Biosimilar Nods

(1/22, Zoey Becker, Fierce Pharma) ...The FDA recently wrapped up its reinspection of Alvotech's facility in Reykjavik, Iceland, and issued yet another Form 483 filing, which flagged just one observation, the company said in a Friday release. The manufacturer plans to respond to the agency "in the following days."...Despite the setbacks, Teva ramped up its collaboration with Alvotech last summer by pledging increased manufacturing involvement and $40 million in funding. The Israeli drugmaker committed to boost its presence at the Icelandic plant and was "actively supporting" Alvotech on-site at the time to prepare for the reinspection... Full

J&J Beats Profit Estimates On Pharmaceutical Unit Strength

(1/23, Bhanvi Satija and Sriparna Roy, Reuters) ...Johnson & Johnson on Tuesday reported fourth-quarter profit above Wall Street expectations, helped by demand for its blockbuster psoriasis treatment Stelara and strength in its medical device unit. It expects higher revenue from its multiple myeloma drug Darzalex and newer oncology drugs such as Carvykti and Tecvayli to help it meet its 2025 pharmaceutical sales target of $57 billion... Full

Paracetamol Maker Granules India Posts Marginal Rise in Q3 Profit

(1/23, Manvi Pant and Kashish Tandon, Reuters) ...Drug maker Granules India reported a marginal rise in third-quarter profit on Tuesday, helped by easing raw material costs. The company's consolidated profit rose 1.6% to 1.26 billion rupees (nearly $15 million), according to an exchange filing... Full

FDA Wants Classwide Boxed Warning On All Commercial CAR-T Therapies Amid Secondary Cancer Safety Probe

(1/23, Angus Liu, Fierce Pharma) ...As many have feared, the FDA's investigation into secondary T-cell cancers following treatment with existing CAR-T therapies is poised to lead to a classwide black box warning. For all six commercial CAR-T therapies, the FDA is requiring label updates to include T-cell malignancies in the boxed warning section of each product's label, according to the agency's separate notification letters dated Jan. 19 to Bristol Myers Squibb, Gilead Sciences' Kite Pharma, Johnson & Johnson and Novartis. A black box warning is the most serious safety alert on a medication's label... Full

Fate of Most Remaining Zantac Lawsuits Weighed by Delaware Judge

(1/22, Brendan Pierson, Reuters) ...GSK, Pfizer and other pharmaceutical companies are urging a judge in Delaware this week to find that evidence plaintiffs' lawyers want to use in about 72,000 lawsuits claiming that the discontinued heartburn drug Zantac caused cancer is not supported by science. If they are successful, that could end much of the long-running litigation over the drug and greatly reduce the risk of hefty damage awards or settlements, which has weighed on companies' shares in recent years... Full

End Drug Shortages Alliance Announces New Chair and Board Members for 2024

(1/22, End Drug Shortages Alliance) ...The End Drug Shortages Alliance announces the appointment of Terri Lyle Wilson, vice president of pharmacy for The Children's Hospital Association, as its new chair. Wilson succeeds past-board chair Eric Tichy, PharmD, MBA, FCCP, division chair, pharmacy supply solutions, Mayo Clinic...Wilson will lead EDSA in its five-year strategy that will include developing drug shortage communication standards across the industry; executing a centralization strategy for communication of drug shortages to all industry stakeholders; and establishing and publishing guidance on inventory management best practices... Full

Expert Panelists Call for More Research On ADHD in Women, Girls

(1/22, Anastassia Gliadkovskaya, Fierce Healthcare) ...Experts called for more research focused on ADHD in girls and women in a panel in New York City last Thursday. The National Institutes of Health, the largest public funder of biomedical research in the world, only funded one study in 2023 focused on ADHD and women, Julia Schechter, co-director of the Duke Center for Girls & Women with ADHD and assistant professor in the Duke Department of Psychiatry and Behavioral Services, said on the panel... Full

Some Countries Are Moving to Digital Prescription Drug Information for Patients. The U.S. Shouldn't Follow Suit

(1/22, John Whyte, STAT Plus) ...Getting a new prescription can be overwhelming: medication schedules, foods to eat or avoid, interactions between different drugs. Having all of these details in accessible, printed documents keeps patients informed and mitigates the risk of medication errors. However, there's a growing movement across the world to eliminate printed medication information, making it harder for patients to learn about the drugs that, in many cases, save their lives. The U.S. must resist the urge to follow suit... Sub. Req'd

Editorial: Bernie Sanders Wants a Pharma CEO Show Trial

(1/22, The Wall Street Journal) ...Mr. Sanders last Thursday announced a committee vote on Jan. 31 to subpoena the CEOs of Johnson & Johnson and Merck to testify about the "outrageously high price of prescription drugs."...Mr. Sanders doesn't want to negotiate, or conduct actual oversight. He wants to keelhaul the CEOs as punishment for suing the government. The CEOs don't have particular knowledge about how their drugs are priced in foreign countries—the ostensible subject of Mr. Sanders's hearing—but both companies have offered to send executives who do... Sub. Req'd

Pharma's Attack On Medicare Drug Price Negotiation Might Benefit Biden

(1/23, John Wilkerson, STAT Plus) ...Pharmaceutical companies are doing anything they can to stop President Biden's Medicare program from being able to negotiate prices for their products, including suing the government. Experts say their efforts might actually benefit Biden by reminding voters that he's taking on big drug companies... Sub. Req'd

Unlikely Political Allies Take On Drugmakers' Patent Tactics

(1/23, Peter Sullivan, Axios) ...Some of the most liberal Democrats in Congress and the House GOP's lead budget writer are backing a plan to keep drugmakers from gaming the patent system...Their legislation targets "patent thickets" - the practice of taking out overlapping patents around one drug that the bill's sponsors say drug companies use to fend off competition...The involvement of Rep. Jodey Arrington (R-Texas), chair of the House Budget Committee, has raised some eyebrows in the pharmaceutical industry and highlights the continued pressure on the sector even after Democrats passed the Inflation Reduction Act to allow Medicare to negotiate drug prices... Full

What Do FTC's Aggressive Moves Against Biopharma Portend For 2024?

(1/22, Brenda Sandburg, Pink Sheet) ...The US Federal Trade Commission took aim at the biopharma industry last year with a series of aggressive enforcement actions in the M&A arena. For the first time it challenged a pharma merger based on a novel theory of anticompetitive harm. It also succeeded in terminating a licensing deal involving a single asset, unraveled a company's reacquisition of an entity it had spun out, and blocked a merger of leaders in programmatic advertising to health care providers... Sub. Req'd

For Clinician-Administered Drugs, Researchers Find No Association Between Price Increases and OOP Cost Increases

(1/22, Zachary Brennan, Endpoints News) ...From 2009 to 2018, the prices of drugs that were administered by doctors, as opposed to ones patients take themselves, rose 4.4% per year. And at the same time, patients' median out-of-pocket costs increased 9.6% per year, accounting for inflation. But there was "no association between changes in drug prices and out-of-pocket costs for individual drugs," the authors wrote. The research was funded by Arnold Ventures, which has advocated for policies to reduce drug spending. The researchers mused on two reasons why prices and costs might both be rising, but not directly linked... Full

Proposed Medicaid Rule Will Only Hurt Providers and the Patients They Serve

(1/23, Brian Nyquist, RealClearHealth) ...While we commend CMS for continuing to propose solutions intended to reduce costs for Medicaid beneficiaries, every policy should be evaluated on its impact across the entire healthcare ecosystem to mitigate unintended consequences. It is imperative that CMS withdraw the stacking policy to protect providers and vulnerable patients who rely on access to essential treatments to optimize their health and well-being... Full

Medicare Part D in 2024: Smaller Pharmacies Abandon Preferred Pharmacy Networks

(1/23, Adam J. Fein, Ph.D., Drug Channels) ...Today, I update DCI's exclusive analysis of how smaller pharmacies will participate as preferred cost sharing pharmacies via the pharmacy services administrative organizations that represent them in negotiations with plans. As you will see below, the largest PSAOs have effectively abandoned PDP's preferred networks in 2024. Plans from Aetna, Humana, WellCare, and UnitedHealthcare will not have any independent pharmacies participating via PSAOs as preferred pharmacies. Smaller pharmacies ability to navigate away provides more bad news for stand-alone Part D market—and another unexpected consequence of the Inflation Reduction Act of 2022... Full

Growing Interest in Modeling Prompts Launch of MIE Program for Generic Drugs

(1/22, Joanne S. Eglovitch, Regulatory Focus) ...Officials from the US Food and Drug Administration explained how sponsors can increase their chances of getting accepted into the new model-integrated evidence pilot program for generic drug applications. The program, which launched on October 1, aims to expedite generic drug development...The goal of the program is to facilitate enhanced scientific communication between generic drug developers and FDA, with a specific focus on using modeling techniques in lieu of conducting in vivo bioequivalence studies to facilitate generic drug development... Full

FDA Sets Aggressive Deadline for Inspection Overhaul

(1/22, John Wilkerson, STAT Plus) ...Food and Drug Administration officials hope to finish this year a massive overhaul of the way the agency inspects facilities that make drugs, medical devices, and food products, they said Friday...The goal of the restructuring is to streamline inspections and the regulatory actions that follow them. The employees who inspect facilities will work closer with those in the product centers so that questions that come up during inspections can be answered on the spot. It's also a huge cultural change, and the agency is trying to get employees ready for that, too... Sub. Req'd

PCMA Report Details Increased Costs Associated with Legal Changes in Tennessee

(1/22, PCMA) ...The Pharmaceutical Care Management Association today released a report finding that recent legal changes taken in Tennessee would increase prescription drug costs for employers, health plan sponsors, and workers by nearly $5 billion. The analysis, prepared by Visante on behalf of PCMA, analyzed the recently enacted Public Chapter 1070 that restricts the use of preferred pharmacy networks. Researchers estimate that Chapter 1070 will likely cost businesses and employees in the State of Tennessee nearly $200 million dollars in its initial year of implementation and increase spending by more than $2 billion over the next 10 years... Full

Canada Adds Hurdles To FL Drug Import Plan, PhRMA Weighs Options

(1/22, Maaisha Osman, InsideHealthPolicy) ...Randall Lutter, senior fellow at Manhattan Institute, told Inside Health Policy, "The Canadian government doesn't want shortages in Canada and the manufacturers don't want drug exports because of the price differential."...The Pharmaceutical Research and Manufacturers of America blasted FDA's approval as "reckless" and a threat to public health, and said it is "considering all options for preventing this policy from harming patients."... Sub. Req'd

Florida's Drug Importation Plan Is A Bipartisan Blunder

(1/22, Sally Pipes, Forbes) ...The Canadian government has warned that allowing Americans to import drugs could cause domestic drug shortages and has vowed to take steps to prevent that, up to and including the rejection of overseas purchase orders. "This is effectively a raid on Canada's drug supply," said Adrian Dix, British Columbia's health minister and a member of the provincial legislative assembly from the socialist New Democratic Party. "It would be a significant issue if this were allowed to happen, but I don't think it will." Fixating on Canada's lower prices for brand-name medications, as importation proponents do, ignores two important facts... Full

UK No Longer Requires ‘Innovation Passport' Designation For Project Orbis

(1/22, Vibha Sharma, Pink Sheet) ...The UK has streamlined its process for companies to make submissions to the MHRA under Project Orbis, the global initiative to fast-track access to promising cancer drugs. Sponsors who want their innovative cancer medicines to be evaluated by the UK Medicines and Healthcare products Regulatory Agency under the global Project Orbis initiative no longer need to get their products onto the UK's Innovative Licensing and Access Pathway first... Sub. Req'd

NHS Drug Shortages Are Partly A Political Failure

(1/22, Tim Bierley, The Guardian) ...The shortage of key drugs in the National Health Service could get even worse if the UK government succeeds in actively sabotaging one of its most important sources of cheap generic medicines in a trade deal with India...The British Medical Association, Médecins Sans Frontières and health organisations in India have all warned that these measures could lead to an increase in the cost of generic drugs, both in the UK and globally. To prevent even worse NHS drug shortages in the future, the government must end its efforts to trash India's finely balanced patent laws... Full

Budget 2024: Pharma Industry Leaders Urge Govt for Conducive Policies and Incentivise Domestic API Manufacturers

(1/23, Sushmita Panda, Financial Express) ...Finance Minister Nirmala Sitharaman will present the Interim Budget 2024 on February 1. Ahead of the Interim Budget 2024, the Pharmaceutical industry emphasised on the need to strengthen the nation's healthcare infrastructure and bolster research and development in the sector. Nikhil Chopra, CEO & Whole Time Director, JB Pharma, said that India faces an increasing disease burden, demanding a sustained and strategic healthcare focus... Full

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