Tuesday, January 30, 2024

Senator Baldwin Demands Big Pharma Stop Unfair Practices that Reduce Competition, Raise Prices for Inhalers

(1/29, United States Senator for Wisconsin Tammy Baldwin) ...Today, Senator Tammy Baldwin (D-WI) called on the four biggest inhaler companies to stop unfairly locking out generics from the market and driving up the cost of inhalers for Americans. Specifically, in letters to AstraZeneca, Boehringer Ingelheim, GlaxoSmithKline, and Teva, Senator Baldwin called on the companies to stop improperly listing patents for inhalers in the Orange Book and stifling competition... Full

Baldwin Calls On Drug Companies to Stop Gaming Patents for Asthma Inhalers

(1/29, Nathaniel Weixel, The Hill) ...Sen. Tammy Baldwin (D-Wis.) is demanding the four largest manufacturers of inhalers stop improperly listing patents in a Food and Drug Administration database, a practice that can delay lower-cost generics from coming to market. In letters sent Monday to AstraZeneca, Boehringer Ingelheim, GlaxoSmithKline and Teva, Baldwin called on the companies to remove their improperly listed patents from the FDA's Orange Book, the federal database where patent and exclusivity information for FDA-approved drugs is listed... Full

Pequot Health Care Chosen for Distribution of Anti-Opioid Drug in Indian Country

(1/29, Brian Hallenbeck, The Day) ...Pequot Health Care, the Mashantucket Pequot-owned pharmacy health service, has begun distributing the first of some 400,000 free doses of life-saving naloxone, an anti-opioid it will send out over the next decade to federally recognized Indian tribes across the country. The distribution is part of the settlement of tribal lawsuits against Teva Pharmaceuticals, one of the drugmakers involved in the nation's massive opioids litigation... Full

Alvotech Marks Denosumab Milestone

(1/29, David Wallace, Generics Bulletin) ...Alvotech's AVT03 proposed denosumab biosimilar to Prolia and Xgeva has passed a pharmacokinetics, safety, and tolerability study compared to Prolia and is advancing into further trials, the company has reported...However, other developers are also chasing Prolia and Xgeva, with Sandoz having previously declared itself the frontrunner. The company has filed its GP2411 version in both Europe and the US. Meanwhile, other firms in the race include Teva with an in-house candidate; Shanghai Henlius Biotech with its HLX14 version that entered Phase III trials in 2022 – with Organon picking up rights outside China and Luye Pharma's Boan Biotech, which recently reported that it was kicking off a Phase III trial... Global Sub. Full

Cipla Points To Large GLP-1 India Opportunity Amid Speculation On Lilly Deal

(1/30, Anju Ghangurde, Generics Bulletin) ...Cipla refers to the transformational potential of GLP-1s in India, a market with 100m-plus diabetics and rising obesity, amid plans for oral semaglutide and speculation on partnering possibilities. A recalibration in the firm's specialty products thrust is also seen...Cipla's executive vice chairperson and member of the founding family, Samina Hamied, will be stepping down from her current position "due to personal and family commitments". The move is effective close of business hours of March 31,, though Ms Hamied will continue to be a non-executive director liable to retire by rotation at the Mumbai-based company... Global Sub. Full

ADHD Medication Recalled Because Bottles May Contain Completely Different Drug

(1/29, Elizabeth Napolitano, CBS News) ...Azurity Pharmaceuticals is recalling some of its ADHD and narcolepsy medication because packages of the drug may contain the wrong pills. The drug maker said in a recent recall notice that it is calling back one lot of Zanzedi 30 mg with lot number F230169A and an expiration date of June 2025. The product is being pulled from shelves after a pharmacist found an antihistamine called carbinoxamine maleate in a package of Zanzedi, the company said... Full

GSK Shoots for RSV Label Expansion in Younger Adults in Europe in Race Against Pfizer's Abrysvo

(1/29, Nicole DeFeudis, Endpoints News) ...GSK is seeking to make its RSV vaccine the first available in Europe that protects adults as young as 50 years old. An approval would open eligibility to younger adults, who are generally at lower risk for severe RSV but may have underlying conditions that raise the threat. The currently available vaccines, including GSK's Arexvy, are approved for adults in the 60-and-older population. Pfizer's Abrysvo is also approved to protect newborns, another high-risk population... Full

Indian Pharma Firm Dr Reddy's Beats Q3 Profit View On Strong US, European Businesses

(1/30, Rishika Sadam, Reuters) ...Indian pharmaceutical firm Dr Reddy's Laboratories beat estimates for third-quarter profit on Tuesday, helped by strong performance in its generic drugs business in key U.S. and European markets. The Hyderabad-based company reported an 11% rise in consolidated net profit to 13.81 billion rupees ($166.17 million) for the quarter ended Dec. 31, compared with analysts' estimates of 12.77 billion rupees, according to LSEG data... Full

Strides Pharma Posts Q3 Profit at Rs 49.67 Crore, Revenue Up 20% On-Year at Rs 1037.67 Crore

(1/30, Tanya Krishna, Financial Express) ...Pharmaceutical company Strides Pharma Science Limited on Tuesday reported its fiscal third quarter profit for the financial year 2023-24 at Rs 49.67 crore against a loss of Rs 80.03 crore during the third quarter of FY23. It posted revenue from operations at Rs 1037.67 crore, up 20 per cent in comparison to Rs 864.85 crore during the corresponding quarter of FY23. The company EBITDA stood at Rs 193 crore, up 66 per cent on-year, led by healthy revenue and gross margin expansion and among the company's best quarters on an absolute number basis... Full

Sun Pharma Q3 Preview: Strong Specialty, Domestic Sales to Put Earnings in Good Health

(1/30, Vaibhavi Ranjan, Money Control) ...Sun Pharmaceutical Industries is expected to deliver another quarter of healthy earnings, with about 10 percent on-year growth in net profit and revenue in October-December 2023, helped by strong sales in the domestic market and its specialty portfolio. The pharmaceutical major is slated to detail its Q3 earnings on January 31... Full

Krka To Plant Its Flag In India With Laurus Labs JV

(1/29, Dean Rudge, Generics Bulletin) ...Krka is throwing its lot in with its long-term contractual partner Laurus Labs to set up a joint venture in Laurus' native India, Krka Pharma Pvt. Ltd, which the Slovenian firm says will enable the production of finished products for new markets where it is not currently present, including India. Set to be established in Hyderabad, the joint enterprise will be 51% in the hands of Krka, with the remainder being held by Laurus. The firms released a joint statement noting that their respective businesses "complement each other."... Global Sub. Full

What Types of Patents Are to Blame for Biosimilar Market Delays?

(1/29, Skylar Jeremias, The Center For Biosimilars) ...Contrary to popular belief, manufacturing patents are not the primary patent type impacting biosimilar market launch delays, according to a recent study published in Value in Health. The Biologics Price Competition and Innovation Act aimed to expedite the commercialization of biosimilars and enhance market access through streamlined regulatory approval and patent litigation procedures. However, more than 50% of biosimilars approved under the BPCIA have faced substantial launch delays, undermining the intended benefits and resulting in financial burdens on health care systems and delayed access to affordable biologic therapies for patients... Full

Vizient Projects 3.8% Drug Price Increase Driven by Specialty Pharmaceuticals

(1/30, Vizient, Inc.) ...Vizient, Inc. projects drug price inflation to grow at 3.8% in the latest Pharmacy Market Outlook. Driven in part by specialty pharmacy, including the increasing utilization of weight loss drugs, it is the highest projected increase since July 2019...Specialty pharmaceuticals, which treat high-cost, complex or chronic conditions such as cancer, infectious-, autoimmune- and pulmonary conditions, make up the majority of the top 15 medications in spend among Vizient Pharmacy program participants. With 42 novel specialty drugs approved in 2023 — and 2024 likely to see a record number of approvals — the projected price increase for specialty medications is 4.18%... Full

Pharma Price Cut Proposals from US Government Could Be Steep, Analysts Say

(1/29, Michael Erman, Reuters) ...Pharmaceutical companies are due to receive by Thursday the U.S. government's opening proposal for what are expected to be significant discounts on 10 of its high-cost medicines, an important step in the Medicare health program's first ever price negotiations. Five Wall Street analysts and two investors told Reuters they expect the negotiations over prices that will go into effect in 2026 to result in cuts ranging from the statutory minimum of 25% to as much as 60% when the final numbers are set in September. The drugmakers and the government are expected to wait until then to disclose them... Full

AstraZeneca to Fight Medicare Drug Price Plan in Federal Court

(1/29, Nyah Phengsitthy, Bloomberg Law) ...A major drugmaker will argue Wednesday that the government price-setting program created to slash prescription drug costs was unlawfully implemented...The drugmaker's case mainly rests on claims that the program's implementation violates the Administrative Procedure Act, taking a swing at implementation guidance and definitions from the Centers for Medicare & Medicaid Services. "The focus of their lawsuit is not on constitutional claims, but instead on choices that the Biden administration has made implementing the law," said Nicholas Bagley, a professor at the University of Michigan Law School focused on administrative and health law... Full

US Says Novo Nordisk Lacks Power to Attack Drug Price Program

(1/29 Nyah Phengsitthy, Bloomberg Law) ...Among its arguments in a cross motion for summary judgment filed Jan. 26 are that Novo Nordisk's challenge are "unreviewable" by the court, citing President Joe Biden's 2022 Inflation Reduction Act. Under the law, the program allows the government to set prices on some of the costliest drugs Medicare covers...Among the nine ongoing lawsuits filed against the Biden administration's program, Novo Nordisk is one of the remaining challenges with an ongoing brief... Sub. Req'd

The Next Health Crisis Is Already Here. We're Unprepared to Fight It.

(1/30, Phyllis Arthur, RealClearHealth) ...In short, the antimicrobials market is fundamentally broken, and we need to repair it. One fix would be to replace the volume-based sales model with something more like a subscription, in which drug developers are compensated for developing new treatments based on the value of the treatment to public health, regardless of the number of doses patients eventually need. Legislation that would do this is actively under consideration in Congress...Passing PASTEUR should be one of Congress' top priorities. AMR is a national security threat we know how to prepare for... Full

Interview: Janet Woodcock's Lasting Influence On FDA

(1/29, Joanne S. Eglovitch, Regulatory Focus) ...This Wednesday will be Dr. Janet Woodcock's last day at the US Food and Drug Administration, capping a remarkable 38-year career at the agency. She's been called one of the most powerful and influential drug regulators worldwide. Last Thursday, Focus sat down with Woodcock in her office at FDA's White Oak campus, where she reflected on her beginnings at the agency: a rather disorienting first day, the mess she inherited at the Center for Drug Evaluation and Research, and her insistence that CDER be moved away from the Parklawn Building to maintain independence from the commissioner's office... Full

FDA's Woodcock Reflects On More Than 30 Years at Agency — And Hints at What's Next

(1/30, Sarah Owermohle, STAT Plus) ..."Some people might say … there were some that didn't work out. Well, that's how accelerated approval is set up. Is that wrong? What's the alternative?" Woodcock said in an interview with STAT. That doesn't mean the longtime official is averse to change. In fact she says the FDA may need many more adjustments to face the current climate of distrust in scientific authorities and health experts...Woodcock spoke with STAT just days before she officially steps down to embark on a life of gardening and grandparenting — and a project she's pretty close-lipped about, aimed at "helping patients" and "technology."... Sub. Req'd

Pharma Litigation Threatens to Limit State Drug Pricing Policy

(1/30, Celine Castronuovo, Bloomberg Law) ...The generic drug industry aims to build on its success in challenging state anti-price gouging laws with a new lawsuit filed in Illinois—the outcome of which analysts say will affect policy makers' willingness to pursue efforts to rein in drug costs...Drug pricing researchers and legal analysts see the AAM lawsuits in Illinois and Minnesota as an attempt to shape how courts apply the Pork Producers decision to the pharmaceutical industry. More AAM lawsuits against states are likely, and analysts say the threat of litigation will be enough to ward some lawmakers away from pursuing a range of drug pricing policies, including affordability review boards and upper payment limits... Full

State Senate Introducing Prescription Drug Pricing Reform Bills

(1/30, Raga Justin, Times Union) ...New York lawmakers are proposing an expansion of the state's role in manufacturing prescription drugs as part of an effort to combat increasing prices for name-brand medication. It would make New York the second state — after California — to pursue such a measure. Senate Democrats are expected to announce a slate of bills intended to driving down prescription drug costs on Tuesday... Sub. Req'd

Florida Looks to Canada for Cheaper Prescription Drugs

(1/29, Paige Sutherl and Meghna Chakrabarti, Wbur) ...Earlier this month, Florida became the first state to get FDA approval to import cheaper drugs from Canada. Will it work? "I think it's very unlikely that for any given patient, it's going to make any difference in their lives. I think the American people should know that this is political theater," Professor Nicholas Bagley says... Full

Drug Shortages Driving Canadians Across Border

(1/29, Clayton DeMaine, True North) ...Shortages of over 1,800 medications are driving Canadians into the United States to seek over 1800 medications are on the drug shortage list in Canada, causing some Canadians to have to travel across the US border to access their essential drugs. Angelle Ritchie, 50, is a musician living in Oshawa, Ont. She's been living with Crohn's Ileitis, a form of inflammatory bowel disease, since she was 18 and has had several bowel resections resulting in short bowel syndrome...Members of Ritchie's group worry that Florida's recently announced plan to ship drugs from Canada into their state will only exacerbate the drug shortages... Full

Medicines for Europe Calls for Simpler SPC Manufacturing Waiver

(1/29, Catherine Eckford, European Pharmaceutical Review) ...According to Medicines for Europe, the Munich District Court's Supplementary Protection Certificate manufacturing waiver, issued in Germany in October 2023, is "in conflict" with the objectives of the waiver. The organisation and its members are "strongly concerned" by the court's first judgement of the waiver... Full

European Regulators Tout Their Accomplishments Against Pharma's Anticompetitive Practices

(1/29, Ed Silverman, STAT Plus) ...European antitrust regulators want you to know that fighting crime in the pharmaceutical industry pays...In Europe, though, the number of enforcement actions has been piling up. The EC opened a formal investigation into whether Teva Pharmaceutical illegally prevented rival companies from introducing versions of a top-selling multiple sclerosis medicine. This was the first time the EC opened a formal investigation into potential antitrust abuses stemming from patent procedures as well as disparaging competing products... Sub. Req'd

UK SMEs Can Help Restock The AMR Toolbox, But Only If The ‘Broken Market' Is Fixed

(1/29, Eliza Slawther, Pink Sheet) ...The UK must build greater capacity and offer funding to support small but "highly innovative" biotechs, which are instrumental in developing solutions to combat antimicrobial resistance, the chief executive of Scotland's NovaBiotics argues. Public funding issues, the "broken commercial market", and challenges in securing investment are the key limiting factors when it comes to the development of new therapies and other solutions to antimicrobial resistance, a conference has heard... Sub. Req'd

Sofia Sees ‘Turbulence Ahead' for Poorer Countries from the Proposed Pharma Package

(1/29, Krasen Nikolov, Euractiv) ...The EU's poorest country is worried that new rules for the pharmaceutical sector will affect its ability to negotiate directly with drugmakers regarding pricing and reimbursement decisions. "To guarantee patient access in member states with a lower GDP, measures that are justified from a financial point of view and fair to society and patients should be adopted to guarantee the provision of lower prices for medicinal products for countries with lower GDP, not equalisation of prices for all countries," the position of the Bulgarian Ministry of Finance, presented to Euractiv, states... Full

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