Tuesday, June 4, 2024

Why Clinicians Should Be Excited About Austedo XR

(6/3, Leah Kuntz and Rakesh Jain, MD, MPH, Psychiatric Times) ...The US Food and Drug Administration has approved Teva Pharmaceuticals' Austedo XR (deutetrabenazine) as a 1 pill, once-daily pill treatment option, available across therapeutic doses (30, 36, 42, 48 mg), indicated in adults for tardive dyskinesia and Huntington disease chorea control. To help share more on the approval, Psychiatric Times sat down with Rakesh Jain, MD, clinical professor of psychiatry at the Texas Tech University School of Medicine - Permian Basin... Full

Drug Overdose Deaths Down in KY, OH and Nation

(6/3, Gilbert McClanahan, WCHS) ...Naloxone is an opioid overdose reversal drug. The shipment is part of Kentucky's settlement with Teva Pharmaceuticals. The company agreed to pay Kentucky more than $71 million over 13 years, and to provide more than 23,000 units of naloxone to be given out in Kentucky each year. All this is happening as the deadly overdose numbers drop. Experts say that's because people are able to get better treatment. The CDC reports overdose deaths are down for the entire country... Full

Lupin Launches Generic Drug For Prevention Of Bacterial Infections In US

(6/3, Press Trust Of India) ...Drug maker Lupin on Monday said it has launched a generic medication used to treat or prevent bacterial infections in the US market. The company has launched Doxycycline for Injection USP (100 single-dose vial) in the US post approvals from the US Food and Drug Administration, the Mumbai-based drug maker said in a statement...Lupin said it has also received tentative approval from the USFDA for its abbreviated new drug application for Letermovir Tablets, 240 mg and 480 mg... Full

Aurobindo Pharma Subsidiary Partners with MSD for Biologics Manufacturing

(6/3, Ekta Batra and Vivek Lyer, CNBC TV 18) ...In an interview with CNBC-TV18, Satakarni Makkapati, CEO of Biologics, Vaccines and Peptides Businesses and Santhanam Subramanian, CFO of Aurobindo Pharma spoke at length about the tie-up with Merck Sharp & Dohme (MSD) to produce biological products... Full

Takeda Outlines Mid-Stage Narcolepsy Data that Prompted 'Rapid' Move into Phase 3

(6/3, Max Gelman, Endpoints News) ...The drug, called TAK-861, was tested at four dose regimens, and all four improved sleep latency scores after eight weeks. Twice-daily regimens recorded higher numerical improvements, and Elena Koundourakis, head of Takeda's orexin franchise, said Monday that those doses showed better profiles. Takeda isn't revealing the pivotal trial design yet for TAK-861, an oral orexin receptor 2 (OX2R) agonist... Full

AbbVie's Humira 2.0 Drug Couple Skyrizi, Rinvoq Will Help Sales Rebound Amid Biosimilar Onslaught: Report

(6/3, Ben Adams, Fierce Pharma) ...Having lost U.S. patent protection at the start of last year, the drug's revenue dropped to $14.4 billion in 2023, down from the record $21.2 billion it made the year before, with an even steeper decline coming in 2024. As GlobalData notes, this major drop in Humira receipts precipitated a 7% drop in AbbVie's overall revenue for that year. But there is another hope for company; two, in fact, in the form of Skyrizi and Rinvoq. "Like Humira, Skyrizi and Rinvoq are within AbbVie's immunology portfolio and cover Humira's major indications, such as psoriasis and arthritis," said Jasper Morley, pharma analyst at GlobalData... Full

Serious Threats, Big Opportunities

(6/3, Debby Garbato, Drug Store News) ...In the past, problems were the bane of independent pharmacies, many of which have disappeared. But poor PBM reimbursements and other financial challenges are now taking their toll on larger chains, particularly drugstores... Full

Bipartisan Efforts To Legislate Pharmaceutical Patent Reform Heat Up

(6/3, Joshua Cohen, Forbes) ...Today, multiple bipartisan bills have been introduced that seek to rein in different ways that drug companies may be abusing the patent system. The Federal Trade Commissioner Lina Khan has chimed in as she targets "improper or inaccurate patent listings ... that keep brand name prices artificially high."...In brief, while bipartisan efforts to legislate or otherwise bring about pharmaceutical patent reform are heating up it's not yet clear if and when material changes will be enacted... Full

AAM Seeks Clarity, Leeway in BA/BE Studies Guidance

(6/3, Ferdous Al-Faruque, Regulatory Focus) ...The Association for Accessible Medicines wants the US Food and Drug Administration to clarify what its expectations of sponsors of bioavailability (BA) and bioequivalence (BE) studies in the agency's recently updated guidance on the topic. It also wants regulators to waive a five-year sample retention requirement if the facility has passed agency inspection... Full

Fierce Fight with No End in Sight for Drug Discount Program

(6/3, Jessie Hellmann, Roll Call) ...On Tuesday, the fight moves to the House Energy and Commerce Oversight and Investigations Subcommittee, which has scheduled a hearing on the issue... "It's hard to imagine 340B legislation going through overnight because it has such a big impact." [said Maureen Testoni, president and chief executive officer for 340B Health]. Her organization argues that the savings from the program allow hospitals to serve their communities and stretch limited resources. By contrast, drug companies argue wealthy hospitals are taking advantage of it to pad their bottom lines instead of passing savings to patients... Full

House 340B Reform Bill Would Require Discount Pass Through, Define Patient, Hospital Eligibility

(6/3, Cathy Kelly, Pink Sheet) ...Legislation is the fruit of PhRMA's lobbying collaboration with the National Association of Community Health Centers. It would also require manufacturers to supply contract pharmacies, within limits... Sub. Req'd

In February, Medicare Began Negotiating Behind Closed Doors for Lower Drug Prices

(6/4, Sydney Lupkin and A Martínez, NPR) ...After a 2022 law lifted the ban on Medicare negotiating drug prices, the government is in talks to lower prices on 10 medicines that cost the program billions of dollars a year... Full

Novartis, PhRMA Sue West Virginia Over Contract Pharmacy Law

(6/3, Nyah Phengsitthy, Bloomberg Law) ...Novartis Pharmaceuticals Corp. and the Pharmaceutical Research and Manufacturers of America are seeking to block West Virginia's law (S.B. 325), filing two separate challenges in the US District Court for the Southern District of West Virginia on May 31...Novartis argues the law violates the supremacy clause of the US Constitution and is preempted under the federal 340B statute and federal laws governing patent protection and regulatory exclusivity periods for drug products... Sub. Req'd

Lawsuits Pile Up Over State Laws On Discounts for Hospitals' Contract Pharmacies

(6/3, Brendan Pierson, Reuters) ...The pharmaceutical industry has filed at least four lawsuits this year challenging state laws requiring drugmakers to offer discounts on drugs dispensed by third-party pharmacies that contract with hospitals and clinics serving low-income populations...All of the lawsuits say that the state laws conflict with the federal law governing a drug-discount program for hospitals and clinics that serve low-income populations, known as 340B. Drugmakers must participate in the 340B program in order to receive funds from government health insurance programs like Medicare and Medicaid... Full

Minnesota Justices Question State's Taxation of Drug Rebates

(6/3, Perry Cooper, Bloomberg Law) ...Three Minnesota Supreme Court justices at arguments Monday seemed likely to agree with a wholesale drug distributor that the state's $500,000 tax bill improperly characterized its drug rebate program. The revenue commissioner wants the high court to overturn a 2023 tax court ruling that Dakota Drug Inc. was right not to include rebate amounts customers earn and then use for future purchases when the company calculated its gross revenue from sales of prescription and generic drugs... Sub. Req'd

Belgian Politicians Raise Concerns On Pharma Regulatory Data Protection Change

(6/3, Nicole Verbeeck, Euractiv) ...In its last stretch, the Belgian Presidency of the Council of the EU is discussing regulatory data protection for medicinal products. The goal is to balance pharmaceutical innovation with timely patient access across the EU. With EU elections just around the corner, Belgian politicians have shared with Euractiv their perspectives on this complex issue... Full

Project Orbis Led To 80% Cut In Submission Gap For Cancer Drugs In Switzerland

(6/3, Eliza Slawther, Pink Sheet) ...The international Project Orbis regulatory collaboration initiative reduced the submission gap between filings made in the US and Switzerland even more than expected, marking a step towards faster access to innovative cancer drugs, regulatory experts have told the Pink Sheet..."We definitely expected a reduction of the submission gap for Orbis MAAs in comparison to non-Orbis MAAs," Ulrich-Peter Rohr and Matea Zosso, two authors of the study, told the Pink Sheet. "However, the magnitude of more than 80% reduction was not expected. A shorter submission gap is the first step to faster patient access to innovative oncology drugs," according to Rohr, deputy head of Swissmedic's clinical assessment division, and Zosso, a senior clinical assessor at the agency... Sub. Req'd

US FDA Guidance On Formulation Development to Bolster Opportunities for Indian Companies

(6/4, Pharmabiz.com) ...The draft guidance on formulation development outlines the regulatory requirements and best practices for developing drug formulations, especially those intended for the US market. Adhering to these guidelines not only ensures compliance but also enhances the quality and efficacy of pharmaceutical products. For Indian pharmaceutical firms eyeing global expansion, such guidance provides a roadmap for developing high-quality formulations that meet international standards, thereby bolstering their credibility and competitiveness in the global arena, said Indian pharma industry experts... Full

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