Thursday, January 11, 2024

Teva: We Have 16 Biosimilars In The Pipeline, Our Aim Is 20

(1/10, Dean Rudge, Generics Bulletin) ...Teva kicked off the first gala investor event of the year by telling attendees that it will look to upsize its existing pipeline of biosimilars, albeit with a continued preference for partnerships. "Our biosimilar strategy is very simple. We want to have a big portfolio, around about 20 products. We have 16 currently in our pipeline. And we want to do that, the majority of that, through partnerships," the Israeli firm's CEO Richard Francis told attendees to the J.P. Morgan Annual Healthcare Conference currently taking place in San Francisco, California... Global Sub. Full

InnovationRx: The Pharma M&A Horizon

(1/10, Katie Jennings and Alex Knapp, Forbes) ...One interesting application for generative AI comes from Teva. According to its CEO Richard Francis, the company has been developing generative AI tools to improve its sales forecasting, enabling the company to optimize its supply chain, inventory management and other aspects of the business. "If we can optimize our inventory levels, from a cash point of view, that's huge," he said... Full

Use of A.D.H.D. Drugs Surged During Pandemic, Study Finds

(1/10, Matt Richtel, The New York Times) ...Prescriptions for drugs used to treat attention deficit hyperactivity disorder surged during the coronavirus pandemic, particularly among women and patients ages 20 to 39, according to new research compiled by scholars affiliated with the U.S. Food and Drug Administration...The reasons are not totally clear, the researchers found, and could include pandemic-related stress, recognition of undiagnosed cases, over-prescription and online marketing of medications... Sub. Req'd

More Adults Sought Help for ADHD During Pandemic, Contributing to Drug Shortages

(1/10, Tom Murphy and Heather Hollingsworth, Associated Press) ...Prescriptions for ADHD treatments surged among adults during the COVID-19 pandemic, helping to fuel lingering shortages that frustrate parents and doctors...Dr. Ann Childress says more adults also started coming to her for help after COVID-19 hit. The Las Vegas psychiatrist sees several reasons behind the shift. Working from home made some people realize how easily they get distracted. Childress says she diagnosed a lot of parents, especially moms, who saw it in their children and realized they may have it as well. Plus, social media made people more aware of adult ADHD... Full

US FDA Allows Import of Syphilis Drug to Address Shortages

(1/10, Christy Santhosh, Reuters) ...The U.S. Food and Drug Administration will temporarily allow the import of a syphilis drug made by France's Laboratoires Delbert, the company said on Wednesday. Laboratoires Delbert said it was coordinating with the health regulator to bring extencilline into the United States to address syphilis drug shortages, according to a letter on the FDA's website... Full

FDA Allows Imports of Syphilis Drug from France Amid Nationwide Shortage

(1/10, Nathaniel Weixel, The Hill) ...Pfizer, which is the only company manufacturing the drug in the U.S., said it would take until at least the second quarter of 2024 to increase production enough to end the shortage. The shortage is coinciding with a significant increase in infections, including syphilis among pregnant people and congenital syphilis... Full

Stada Waits For SPC Expiry Before Launching First Stelara Biosimilar In EU

(1/10, Ian Schofield, Pink Sheet) ...The European Commission has approved Stada/Alvotech's Uzpruvo (ustekinumab), the EU's first biosimilar version of Janssen's originator drug Stelara, for the treatment of Crohn's disease, psoriasis and psoriatic arthritis. The EU marketing authorization "paves the way for market entry as soon as possible" following the July 2024 expiry of a supplementary protection certificate (SPC) on Stelara, the companies said...While Stada and Alvotech are waiting until the expiry of the SPC on Stelara to launch their product, another company, Germany's Formycon, has taken a different approach. In October last year, the Munich Regional Court in Germany issued a preliminary injunction against Formycon's plans to manufacture its version of Stelara (FYB202) in Germany before the expiry of the German SPC on July 20, 2024... Sub. Req'd

Amneal Launches Generic Version of FML Ophthalmic Suspension

(1/10, Brian Park, PharmD, MPR) ...The first generic version of FML suspension (fluorometholone ophthalmic suspension) has been made available by Amneal Pharmaceuticals. Fluorometholone ophthalmic suspension is indicated for the treatment of corticosteroid-responsive inflammation of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe... Full

Amneal Touts 39 Retail, Injectable Product Launches in 2023

(1/10, Sandra Levy, Drug Store News) ...In the fourth quarter of 2023, Amneal launched 13 new products, including five injectables. New injectable products include potassium phosphate vials, tranexamic acid and esmolol intravenous bags. These launches provide a strong foundation for higher injectable revenues going forward. In addition, Amneal launched several key new retail products in the fourth quarter, including spironolactone suspension with 180-day exclusivity, valsartan and hydrochlorothiazide tablets and icosapent capsules... Full

Celltrion Sharply Revises Up Earnings Goals to Overtake Amgen

(1/11, Yoo-Rim Kim, The Korea Economic Daily) ...Celltrion Inc., South Korea's leading biosimilar maker, on Wednesday expressed its ambition to join the top 10 global pharmaceutical and biotechnology companies and sharply revised up its earnings goals just a few hours after unveiling its initial targets. "We are aiming to overtake Amgen within the next seven years and rise to the top 10," Seo Jung-jin, founder and chairman of Celltrion Group, said at a press conference... Full

[JPM 2024] Celltrion Will Keep Developing, Manufacturing Biosimilars Until Everyone Has Access to Medication: Founder

(1/11, Lee Han-soo , Korea Biomedical Review) ...Speaking during a Q&A session after his son, Seo Jin-seok, co-Chairman of Celltrion, made a presentation about the company at the J.P. Morgan Healthcare Conference 2024, the founder of Celltrion laid out a visionary plan for the future of biologics and healthcare investment...Seo's plan involves a significant shift in the pharmaceutical industry's approach, moving from a profit-centric to a patient-centric model. The plan includes lowering costs and expanding access so that patients have access to quality drugs... Full

JPM24: Riding Label Expansions and Launches, AZ Plots Course Toward 'Industry-Leading Growth' by 2030

(1/10, Zoey Becker, Fierce Pharma) ...With a late-stage pipeline spanning more than 120 clinical trials and a firm grasp of five major disease areas, AstraZeneca appears confident heading into 2024. But the drugmaker also has its sights set on a farther goalpost: 2030. By that year, AZ aims to deliver "industry-leading growth" and be at least a top-3 player in each of its five focus areas. Those fields are oncology, cardiovascular disease, renal and metabolism, respiratory and immunology, vaccines and immunotherapies and rare diseases... Full

JPM24: After 'Clearing the Decks,' Alkermes Ready to Roll As Pure-Play Neuroscience Company

(1/10, Kevin Dunleavy, Fierce Pharma) ...Age 37 might be old for a "coming-out party," but that's the situation for Alkermes at this year's J.P. Morgan Healthcare Conference, chief operating officer Blair Jackson said in an interview..."2023 was a year of resetting and clearing the decks and simplifying the story," Jackson said. "We've always been a neuroscience company at our core. But we had all this complexity and it was hard for investors to get their arms around." Alkermes eliminated the complexity in 2023. Two months ago, the company completed its split from its cancer business, creating an independent, publicly traded, clinical-stage company called Mural Oncology... Full

Ozempic Mania Fuels Deal Optimism Across Drug Industry

(1/10, Naomi Kresge, Michelle F. Davis and Robert Langreth, Bloomberg) ..."Opening new markets like obesity is adding optimism," said Victor Bulto, president of the US unit for Novartis AG on the sidelines of the JPMorgan Healthcare Conference, which draws the heads of the world's biggest drug companies who use the annual confab to broker multibillion-dollar deals. The renewed energy in biotech, which has been pummeled in recent years, applies even for companies that aren't working in obesity, Bulto said. "The realization that there's still a substantial unmet need" is boosting the excitement, he said... Sub. Req'd

Courts Will Decide the Future of Medicare's Power to Negotiate Drug Prices Within Months

(1/11, Rachel Cohrs, STAT Plus) ...District court judges could soon weigh in on the litany of court cases that major companies filed against the government — shedding light on whether drugmakers have any hope of postponing the first parts of the negotiation process, scrapping it entirely, or sending the issue up to the Supreme Court. It's a major moment for the Biden administration, too, as the White House ramps up its efforts to take credit for the new changes in the 2024 election. The first round of legal decisions will play out in the thick of campaign season, attorneys told STAT... Sub. Req'd

IRA Lawsuits Continue As CMS Approaches Initial Offer Deadline

(1/10, Gabrielle Wanneh, InsideHealthPolicy) ...Nine lawsuits remain in play against Medicare's new drug price negotiation program as CMS draws closer to submitting its initial pricing offers to participating drug companies on Feb. 1, which will kick off a back-and-forth process through Aug. 1 aimed at lowering the prices for 10 of Part D's most expensive medicines. One major looming question, Georgetown O'Neill Institute Health Policy and the Law Initiative Director Zachary Baron told Inside Drug Pricing, is whether other judges will fall in line with an Ohio district judge's ruling in the Chamber's case that the negotiation program is voluntary so there is no grounds for drug makers to argue they are unconstitutionally being compelled to participate... Sub. Req'd

Former FDA Chief Gottlieb: IRA Increases FDA, CMS Tensions

(1/10, Maaisha Osman, InsideHealthPolicy) ...Although some say the increased dialog between CMS and FDA driven by the Inflation Reduction Act could alleviate tensions between the agencies, former FDA Commissioner Scott Gottlieb worries CMS' implementation of the drug price controls in the law might have the opposite effect. He argues that CMS, in its congressionally mandated efforts to reduce prices of brand drugs, may make medical determinations that conflict with FDA guidelines and approvals... Sub. Req'd

Pharma CEO: Let's Have Transparency in Prescription Drug Pricing

(1/10, Medical Economics) ...Our process of getting patients the medication they need is opaque and confusing. Almost a quarter of Americans with insurance have reported that a prescription was unavailable through their plan or required a very high copay. Nearly one in five were surprised to discover that their plans wouldn't pay for care they thought was covered. Americans deserve better, starting with greater transparency. It's time for pharmaceutical companies and others to innovate and disrupt the distribution side of treatment, not just the medical side... Full

How Generic Drug Sponsors Can Ask FDA to Reconsider Applications: New Draft Guidance Explains

(1/10, Lia DeGroot, Endpoints News) ...The FDA is clarifying instances where generic drug applicants can request that the agency reconsider an application, according to an updated draft guidance published Wednesday..."The procedures and policies described in this guidance are intended to formalize FDA's current and historical practices and to continue to promote rapid and fair resolution of eligible requests between an applicant and FDA," FDA wrote... Full

FDA Pushes Back On Calls For Safety Tests Of Generic Drugs

(1/10, Arthur L. Kellermann, Forbes) ...Currently, American patients, doctors and hospitals have no way to differentiate high-quality generic drugs and the companies that make them from the manufacturers that cut corners. The FDA's approach to monitoring can take years to spot a problem. The only way to strengthen the process is to independently evaluate the quality of generic medicines in accredited labs before they are sold. There's only one problem. The FDA is pushing back on calls for independent testing... Full

Would I FIE to You? FDA's First Interchangeable Exclusivity Determination Results in Expiration

(1/11, Sara W. Koblitz, FDA Law Blog) ...FDA explained the public health benefits of this interpretation: it encourages applicants to submit aBLAs as soon as practical to increase competition and access. If the expirations clock starts ticking before the application for the interchangeable product has been submitted, "applicants may choose to either delay submitting their BLA until they have a data package that can support licensure of their proposed product as an interchangeable, or they may submit an application for biosimilarity only, and may not seek licensure as interchangeable at all because their biological product will likely not have a chance to benefit from FIE."...But the main takeaway from this FIE expiration determination is that it's only interchangeable approval and litigation that count towards the FIE expiration calculations... Full

Editorial: When Biden, Trump and DeSantis Agree on Something, Watch Out

(1/10, The Wall Street Journal) ...Joe Biden, Ron DeSantis and Donald Trump agree on something. All three presidential candidates want to import pharmaceutical price controls from countries with socialized healthcare systems and outsource drug regulation to foreign governments. That's the point of Florida's plan to import drugs from Canada, which the Food and Drug Administration approved last week...Drug makers say they'll reduce sales to Canada if their products will be exported to the U.S. Canada has warned it would restrict drug exports to the U.S. to prevent shortages. On Monday Ottawa said it "is taking all necessary action to safeguard the drug supply and ensure Canadians have access to the prescription drugs they need."... Sub. Req'd

Federal Health Minister Says He Won't Allow Florida To 'Pillage' The Drug Supply

(1/10, John Paul Tasker, CBC News) ...Health Minister Mark Holland says Florida's plan to import cheaper Canadian pharmaceuticals is a non-starter and the federal government will use its regulatory power to ensure the national drug supply does not face any shortages due to actions by a foreign state. "There is no way we will allow any jurisdiction, be it a state or another foreign jurisdiction, to endanger the Canadian drug supply. That is not an appropriate solution to whatever challenges they may be facing," Holland said during an official announcement in Nova Scotia of a bilateral health-care deal with the province... Full

States' Big 2024 Health Plans: Workforce Support and Cheaper Drugs

(1/11, Maya Goldman, Axios) ...As state legislatures get back to work across the country, state policymakers are eying measures to bolster their burned-out health care workforces, make prescription drugs more affordable and reform their Medicaid programs...States are expected to be far more active this year, as policymakers look to continue pandemic recovery efforts and address voter concerns over health care costs. "Coming out of the pandemic, there has been just so many different challenges that have been exacerbated, I think, with more strain across the system," said Hemi Tewarson, executive director of the National Academy for State Health Policy... Full

Virginia Legislators Reintroduce Plan to Establish a Prescription Drug Affordability Board with Bipartisan Support

(1/9, Joe Dodson, Courthouse News Service) ...A bipartisan coalition of Virginia lawmakers, aiming to help lower prices, announced plans during the conference to reintroduce a bill to develop a Prescription Drug Affordability Board. Should it pass this session, Virginia would join the likes of Colorado and Minnesota as the ninth state in the country to develop such a board...Delegate Karrie Delany, a Democrat, told reporters she expected less opposition to the bill this time, as time has allowed Republican lawmakers to realize the near-universal support for the board... Full

Biosimilars Forum Welcomes Biocon Biologics as Newest Member

(1/10, Biosimilars Forum) ...Biocon Biologics, a subsidiary of Biocon Ltd., joins the Forum's efforts in advocating to make more affordable biosimilars more accessible to patients who need them. Biocon Biologics is a fully dedicated biosimilars company in the United States and around the world. Strengthened by the acquisition of the biosimilars business of its long-term partner Viatris, Biocon Biologics provides life-improving medicines in a range of therapeutic areas, including diabetes, oncology, and immunology... Full

IQVIA Report Flags Challenges With Biosimilar Access, Savings Throughout Europe

(1/10, Skylar Jeremias, The Center For Biosimilars) ...IQVIA's most recent white paper on the impact of biosimilar competition in Europe highlighted enduring access and savings growth challenges and called for more focus on policies ensuring a sustainable market and robust pipeline...The goal of the white paper was to provide new insights while acknowledging the enduring relevance of past observations, such as shifts in originator strategies, assessments of net savings in health care spending, identification of emerging biosimilar manufacturers' locations, and the growing gap in access... Full

India Could See Drug Shortages, Price Rise Owing to New Rule: Industry Executives

(1/11, Teena Thacker, The Economic Times) ...India may see drug shortages and an escalation in drug prices in the coming days, according to industry executives, as several lobby groups and associations that represent medium and small enterprises have expressed their inability to follow the rules recently mandated by the health ministry and said they expect closure of several units... Full

India to Demand Faster Inspection of Pharma Firms by USFDA; Raise Export Regulations at TPF on Friday

(1/10, Press Trust Of India) ...India will strongly demand fast-tracking American health regulator's USFDA inspections, or audit of domestic pharma firms, lifting export ban on wild caught shrimp and flag the issue of export control regulations for high tech products and technologies at the Trade Policy Forum meet on Friday, an official said. The 14th TPF meet will be co-chaired by US Trade Representative Katherine Tai and Commerce and Industry Minister Piyush Goyal here. The Indian side will also raise the issue of reinstating the Generalized System of Preferences status to India, the official said... Full

Experts Suggest Manufacturers and Buyers Share Increased Freight Costs Amid Rising Shipping Challenges

(1/11, Pharmabiz.com) ...Freight rates have increased by more than 100% to 150% inclusive of all surcharges over the past 10 days as shipping carriers have changed route via Cape of Good Hope around Africa to reach Europe and the US, badly impacting pharma exports. According to Sumanta Choudhury, advisor, Pharmaceuticals Export Promotion Council of India (Pharmexcil), "The burden of additional freight should be cautiously worked out in collaboration with insurance companies. Insurance companies should come forward with a special package. Also, the buyer-seller contracts need careful revision to avoid Covid like situations."... Full

India Pledges 'Appropriate Action' After Completing Cough Syrup Bribe Probe

(1/10, Krishna N. Das, Reuters) ...India will take "appropriate action" after completing an investigation into a complaint that a drug regulator helped switch samples of cough syrup linked to the death of children in Gambia in return for a bribe, two officials said on Wednesday... Full

China Regulation in Year Of The Dragon: Good Distribution Practice, Corporate Law, Export Bans

(1/10, Brian Yang, Pink Sheet) ...A plethora of new and revised regulations in China to regulate drug distribution and storage, the set up of new corporations, administrative appeals, as well as the export of gene editing technology, are set to come into effect in 2024, ushering in more challenges to pharma and life sciences companies operating in the country... Sub. Req'd

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