Friday, July 12, 2024

Piper Sandler Reiterates Overweight Rating on Teva Pharma (TEVA)

(7/12, StreetInsider.com) ...Piper Sandler analyst David Amsellem reiterated an Overweight rating and $20.00 price target on Teva Pharma, The analyst commented, "With Indivior (INDV; not covered) recently announcing the discontinuation of Perseris, its long-acting injectable (LAI) form of the atypical antipsychotic risperidone, we thought it made sense to dig into commercial dynamics surrounding Teva's LAI risperidone product Uzedy."... Sub. Req'd

AbbVie's Humira is Still On Top, But Biosimilars Are Chipping Away at its Dominance

(7/11, Zachary Brennan, Endpoints News) ...The cracks in AbbVie's once-impregnable armor have come mostly from a partnership between Sandoz and CVS' private-label drug unit Cordavis. CVS' move in September to start preferring Sandoz's Hyrimoz has given the drug 13% of the market. But according to Samsung's latest quarterly report, the other nine Humira biosimilars have captured just 5% of the total market. The issue isn't price... Full

Samsung Report Shows Biosimilars Struggle in Immunology, Succeed in Oncology

(7/11, Elizabeth S. Eaton, FirstWord Pharma) ...That rapid market share erosion is, in part, due to CVS Caremark's January decision to replace Humira with biosimilar versions of the antibody, the first major pharmacy benefit manager in the us to do so. In April, shortly after Humira was dropped from CVS's formularies in favour of Sandoz's Hyrimoz, the biosimilar saw an "explosion" in new prescriptions. According to Samsung's report, Hyrimoz accounts for about 10% of sales now, while the rest of the adalimumab biosimilars have only managed to accrue a percentage or two... Sub. Req'd

Apotex Secures Canadian License For Loqtorzi From Coherus

(7/11, Adam Zamecnik, Generics Bulletin) ...Apotex has secured an exclusive license to Coherus Biosciences' Loqtorzi (toripalimab) in Canada, branching out the company's oncology portfolio with the first novel brand biologic drug. The deal gives Apotex exclusive rights for the product's commercialization in Canada following toripalimab's anticipated approval in the country... Global Sub. Full

ANI Acquires Alimera Sciences To Bolster Ophthalmology Portfolio

(7/12, Adam Zamecnik, Generics Bulletin) ...ANI has acquired Alimera Sciences in a move to expand its rare disease business, highlighting its increasing drift from generics. ANI Pharmaceuticals will acquire Alimera Sciences in a deal that values the firm at $381m in upfront consideration, after signing a definitive agreement in a move that is seen as an effort to gain a foothold in ophthalmology and expand its rare diseases business... Global Sub. Full

The End of the Beginning: Lilly Execs Eye Top Spot in Burgeoning Alzheimer's Market After Kisunla's FDA Approval

(7/11, Fraiser Kansteiner, Fierce Pharma) ...The green light—which cleared Kisunla to treat adults with early symptomatic Alzheimer's disease—marks the culmination of more than 30 years of work in the disease field by Eli Lilly. Those efforts also required concurrent development of non-therapeutic resources like diagnostics to detect amyloid plaque in the brain, Dawn Brooks, global development leader for Alzheimer's disease at Eli Lilly, said in a recent interview... Full

Cipla's Verma Succeeds Kabi US Veteran Ducker As CEO

(7/12, Dean Rudge, Generics Bulletin) ...Guided by the firm's ‘Vision 2026' strategy, Fresenius Kabi has tapped Cipla executive Arunesh Verma to lead Fresenius Kabi USA, as former head John Ducker retires after 35 years. Already with a great deal of experience across a who's-who of generics and biosimilar firms, Cipla USA's president and CEO, Arunesh Verma, is taking up a new challenge... Global Sub. Full

Senate Passes Cornyn, Blumenthal Bill to Lower Drug Costs

(7/11, United States Senator for Texas John Carnyn) ...This bill places a reasonable limit on the number of patents a manufacturer can contest, preventing a "patent thicket." This will help deter branded manufacturers of biologics from gaming the system to increase the number of patents they assert, while preserving the incentives provided by the patent system to encourage the core innovation that produces new biologic treatments in the first place... Full

Cornyn-Blumenthal Legislation Would Encourage More Generic and Biosimilar Competition in the Prescription Drug Market to Help Lower Costs for Patients

(7/11, PCMA) ..."As Congress seeks to address drug prices, patent abuse legislation should be the top consideration. In fact, the Congressional Budget Office scores eliminating "patent thickets" as saving $1.8 billion. Conversely, the pharma-backed "delinking" policy does absolutely nothing to lower prescription drug costs but would saddle seniors with higher premiums while boosting profits for big drug companies by $10 billion each year."... Full

Bill Would Cap Prescription Costs for 173 Million Americans, Sen. Casey, Warnock Say

(7/11, Bill Shannon, WTAJ) ...Senators Bob Casey and Raphael Warnock introduced a new bill before Thursday's Aging Committee hearing on lowering health care costs. The Capping Prescription Costs Act would cap annual out-of-pocket prescription drug costs at $2,000 for individuals — $4,000 for families — for all 173 million Americans with private health insurance... Full

As Feds Crack Down On PBMs for Drug Costs, Big Pharma Could Lose some of the Heat

(7/11, Michael Gibney, PharmaVoice) ...Pharma executives and lobbyists have long sought to shift the blame for U.S. drug costs to the industry's price-negotiating middlemen. Now, with the release of an FTC report this week pointing out the "enormous power and influence" these pharmacy benefit managers wield in the healthcare system, drugmakers might see some validation on that front... Full

Opposition Continues To Grow Against FTC Interim Report

(7/11, PCMA) ...Momentum against a pre-determined, non-substantive FTC report is gaining steam as Daniel J. Gilman, senior scholar of competition policy with the International Center for Law and Economics and former Federal Trade Commission staffer, and Jessica Melugin, director of the center for technology and innovation at the Competitive Enterprise Institute, each published blogs pointing out severe flaws in the report... Full

House GOP Leaders To HHS: Quickly Peg Regs, Court Cases Affected By Chevron's Demise

(7/11, Sigi Ris, InsideHealthPolicy) ...Key House committee GOP chairs have given HHS and other agencies until the end of the month to identify all planned and current regs and guidance documents, as well as ongoing and prior court cases, dating back to Jan. 20, 2021, where agencies relied on the Chevron deference recently shot down by the Supreme Court. House Committee on Oversight & Accountability Chairman James Comer (KY) joined fellow House GOP committee leaders in sending leaders to dozens of agencies including HHS, demanding they respond by July 31... Sub. Req'd

Medicare Rx Negotiation More Insulated From SCOTUS Fallout, But Some Key CMS Decisions Could Be Vulnerable

(7/11, Sarah Karlin-Smith, Pink Sheet) ...Experts expect litigation challenging Medicare's definitions of single-source drug and bona fide marketing to get a boost from recent Supreme Court rulings, but overall, the IRA is likely better positioned in a post-Chevron world than older Medicare statutes... Sub. Req'd

Insurers, Employers See Payoffs Switching to Smaller PBMs

(7/11, Lauren Berryman, Modern Healthcare) ...Smaller pharmacy benefit managers may be having more than a moment as some health insurers and employers show the major players the door. Insurance companies and employers fed up with commonplace industry practices are ditching PBMs owned by CVS Health, Cigna Group and UnitedHealth Group, and instead are inking contracts with smaller competitors pushing transparent business models... Sub. Req'd

Bill to Curb Pharma 'Patent Thickets' Sails Through Senate

(7/11, Anna Bratulic, FirstWord Pharma) ...In a rare showing of bipartisan unity, the US Senate unanimously passed a bill Thursday aimed at preventing pharmaceutical companies from creating so-called "patent thickets" around biologics as a way to block biosimilar competitors. The proposed legislation, a scaled-back version of the Affordable Prescriptions for Patients Act of 2023 (S.150), seeks to curb abuses of the patent system by limiting the number of patents a drugmaker can assert in infringement lawsuits against potential biosimilar rivals... Sub. Req'd

Senate Unanimously Passes Bipartisan Pharma Patent Bill

(7/11, Zachary Brennan, Endpoints News) ...The bill, which the CBO said could reduce the federal deficit by $1.8 billion over 10 years, seeks to prevent patent thickets, a tactic wherein pharma companies deploy dozens of patents to protect products from competition. (AbbVie's Humira is often held up as an example.)...But the legislation, which doesn't currently have a companion bill in the House, no longer includes a section going after "product hopping," which is when companies switch patients to a follow-on product that is covered by a later-expiring patent... Full

Advocates Applaud Senate Passage Of Patent Thicket Reform Bill

(7/11, Gabrielle Wanneh, InsideHealthPolicy) ...The Senate on Thursday (July 11) unanimously passed a bill that would combat drug companies' use of patent thickets and other tactics to delay the entry of generic and biosimilar competition into the drug market, a long-awaited victory for drug pricing reform advocates and lawmakers who had been calling on Senate leadership for more than a year to move this and other drug patent reforms forward to aid in lowering prescription drug costs for patients and payers... Sub. Req'd

CSRXP Applauds U.S. Senate Passage of Bipartisan, Market-Based Solution to Crack Down On Big Pharma's Patent Thickets

(7/11, The Campaign for Sustainable Rx Pricing) ...[CSRxP executive director Lauren Aronson] "We encourage lawmakers in both chambers to continue working in a spirit of bipartisan collaboration to ensure this solution is passed into law and to build on the momentum for action with additional market-based solutions to lower drug prices for patients by holding Big Pharma accountable."... Full

Republicans Should Target Big Pharma's Patent Abuse, Not PBMs

(7/11, Ryan Costello, RealClearHealth) ...Big Pharma is trying to capitalize on concerns around the affordability of prescription drugs to bait and switch Congress into passing legislation that would directly boost revenue for drug companies, increase their power over drug prices and increase costs for American patients, taxpayers, and employers...That's why Republicans in Washington should pay attention now and reject Big Pharma-backed calls for a deal with Democrats to impose greater government control and regulation in health care by undermining the role of PBMs... Full

Revised Q&A Guidance Gives Firms More Tools to Deal with Misinformation – Or Does It?

(7/11, Bob Pollock, Lachman Consultants) ...While FDA typically instructs readers that draft guidances are not official and cannot be implemented, we all know that draft guidances outline current Agency thinking. So, my view is that the enforcement policy outlined in the guidance regarding correcting misinformation was okay ten years ago, and that along with the rampant increase in misinformation, the revised guidance likely will permit firms to take advantage of this newly defined enforcement discretion, and the question of whether the guidance is in draft or final ultimately lands in the Agency's lap anyway... Full

AstraZeneca Sues Minnesota AG Over Drug Prices

(7/11, Felicity Dachel, Kare 11) ...A lawsuit by AstraZeneca Pharmaceuticals seeks to have a Minnesota law related to drug prices declared unlawful, saying the state went against federal law in its effort to lower drug prices..."This expansion of the 340B program under state law directly conflicts with federal law," the lawsuit states. According to the lawsuit, price controls can disincentivize innovation and destabilize markets... Full

California Insulin Funding Delayed With No Implementation Date

(7/12, Andrew Oxford, Bloomberg Law) ...Insulin created for the state's CalRx label won't get Food and Drug Administration approval in 2024, according to state officials, and $50 million in funding for the program has been deferred to mid-2025. The state agency overseeing the initiative, however, says the nonprofit group contracted to manufacture the drugs, Civica, has been in talks with federal regulators about the approval process. Civica "has a clear path forward" following recent meetings with the FDA, Andrew DiLuccia, a spokesperson for the state Department of Health Care Access and Information, said... Sub. Req'd

California Congresswoman Katie Porter, House Colleagues Introduce Bill to Lower Prescription Drug Prices

(7/11, Sierra Sun Times) ...Reps. Katie Porter (D-CA) and Rosa DeLauro (D-CT) on Wednesday introduced legislation to help prevent overcharges for prescription drugs. While insurance copays often significantly decrease the cost of a medication, it is sometimes cheaper for a patient to pay without insurance. The Lowest Price for Patients Act will set a simple standard: no patient can be charged a copay for a drug that is higher than the previous years' national average retail price for that drug... Full

Pharmacy Benefit Manager Reform Bill Heads to Shapiro's Desk

(7/11, Ian Karbal, Pennsylvania Capital-Star) ...A bill to regulate pharmaceutical industry middlemen known as pharmacy benefit managers has passed both chambers of the Pennsylvania legislature. It will go to Gov. Josh Shapiro's desk, and he's expected to sign it...The bill passed the House on Thursday afternoon after making its way through the Senate Wednesday. It creates a host of new regulations for pharmacy benefit managers, however it also allows for significant exemptions to those rules. The bill's sponsor, Rep. Jessica Benham (D-Allegheny) said, "It is a piece of legislation that is going to go a long way towards addressing the issues that our community pharmacies are facing and it's also going to save patients some money."... Full

European Commission Drug Shortage Pilot Study Highlights Industry, Regulatory Challenges

(7/11, Ferdous Al-Faruque, Regulatory Focus) ...The European Commission has published results from a pilot study to understand the challenges to ensuring safe drug supply chains. While the commission said that one of the major challenges was getting information about critical medical products, it also noted the study has many shortcomings, making it hard to interpret the data... Full

New UK Government ‘Championing' Life Sciences, But No ‘Big Changes' Expected For Pharma

(7/11, Eliza Slawther, Pink Sheet) ...While the new Labour government includes several "life sciences champions" and has pledged to turn the UK into a life sciences powerhouse, the UK BioIndustry Association head says major changes are unlikely for the pharma and biotech industry... Sub. Req'd

Caveated Confidential Pricing Arrives In Germany But May Not Prove Attractive To Companies

(7/11, Francesca Bruce, Pink Sheet) ...New provisions to introduce confidential drug pricing in Germany are a step in the right direction, but the conditions attached mean that many companies will not qualify while other may not want to, said Alexander Natz, Secretary General of EUCOPE, the organization that represents small and medium-sized pharma and biotech companies in Europe... Sub. Req'd

India's Expertise in Computational Chemistry to Propel Drug Development: Krishnakumar Muraleedharan

(7/12, Pharmabiz.com) ...India's adoption of computational chemistry is supported by a large pool of skilled scientists, specialized academic programmes, and cost-effective research infrastructure, attracting significant global pharmaceutical investments, said Krishnakumar Muraleedharan, country manager, Cresset India... Full

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