Friday, March 29, 2024

Lupin Gets USFDA Nod for its Generic Drug to Treat Seizures

(3/29, Financial Express) ...The approval has been granted to market a generic equivalent of Aptiom Tablets, 200 mg, 400 mg, 600 mg, and 800 mg, of Sumitomo Pharma America, Inc. Lupin is one of the first ANDA applicants and may be eligible for 180 days of shared generic exclusivity. The product will be manufactured at Lupin's Pithampur facility in India... Full

Aurobindo Pharma Arm Extends Negotiations Deadline With MSD for Contract Manufacturing Operations

(3/28, Press Trust Of India) ...Aurobindo Pharma on Thursday said the deadline for negotiations between its arm CuraTeQ Biologics and Merck Sharp & Dohme Singapore for contract manufacturing operations for biologicals has been extended till May next year. Last year in October, CuraTeQ Biologics Pvt Ltd and Merck Sharp & Dohme Singapore Trading Pte Ltd and its affiliates (MSD) had signed a letter of intent (LoI) for contract manufacturing operations (CMO) for biologicals, whereby the parties intended to conclude the negotiations by March 31, 2024... Full

Intra-Cellular Sues to Stop 7 Copies of Its Only Drug, Caplyta

(3/28, Christopher Yasiejko, Bloomberg Law) ...The asserted patents cover compositions and methods for treating sleep disorders and other disorders using lumateperone, according to complaints filed Wednesday against Aurobindo Pharma Ltd. and Thursday against Alkem Laboratories Ltd., Dr. Reddy's Laboratories Ltd., Hetero Labs Ltd., Zydus Lifesciences Ltd., MSN Laboratories Private Ltd., and Sandoz Inc. in the US District Court for the District of New Jersey... Sub. Req'd

Amneal Pulls 4 Lots of Antibiotic Vancomycin Due to Potentially Overfilled, Extra-Potent Bottles

(3/28, Zoey Becker, Fierce Pharma) ...The recall covers four different packaging formats of the company's generic vancomycin hydrochloride for oral solution, which treats intestine inflammation (or enterocolitis) caused by bacteria, plus colon inflammation (pseudomembranous colitis) caused by antibiotic-related C. difficileinfection. Some bottles "may have been overfilled" during the manual bottle-filling stage of manufacturing, the FDA noted in its recall announcement... Full

Rite Aid Strikes Deal to Hand Control to Creditors, Settle Opioid Claims

(3/28, Alexander Gladstone, The Wall Street Journal) ...The deal, if approved by bankruptcy court, will cut more than $2 billion of debt and keep much of the Philadelphia-based company's network of drugstores intact. The official committee of tort claimants, which represents plaintiffs who filed lawsuits against Rite Aid alleging injury from opioids, would share with other holders of general unsecured claims a total cash amount of up to $47.5 million, paid over time, 10% of the company's stock and some potential proceeds from insurance policies... Sub. Req'd

AscellaHealth Releases Q1 2024 Specialty & Rare Pipeline Digest™: Captures Data and Progress of Groundbreaking Therapies in 2024

(3/28, AscellaHealth) ...AscellaHealth, a global healthcare and specialty pharmacy solutions organization, today released its latest Specialty & Rare Pipeline Digest™, the industry's most comprehensive quarterly resource of new, pending and upcoming Specialty and Rare Disease drug launches, cell and gene therapies, biosimilars and generics. Continuing its tradition of providing a quarterly, complimentary, digital source of industry information to support the specialty drug market needs of all stakeholders and decision-makers, AscellaHealth captures essential information and updates on products that may impact treatment for millions of individuals worldwide who are affected by complex, chronic conditions or rare diseases... Full

US HHS Secretary Xavier Becerra, Debbie Dingell Talk Drug Pricing at Ann Arbor Senior Center

(3/29, Shane Baum, The Michigan Daily) ...Xavier Becerra, U.S. Secretary of Health and Human Services, visited Ann Arbor Thursday morning to tour Michigan Medicine's Turner Senior Resource Center with U.S. Rep. Debbie Dingell, D-Ann Arbor, and discuss drug pricing as part of the Biden administration's Investing in America agenda...At the beginning of the event, Dingell said she believes the Inflation Reduction Act, which aims to reduce the federal deficit and lower prescription drug costs, is helping seniors access necessary prescription drugs without imposing a heavy financial burden... Full

Bernie Sanders Wants to Meet Novo CEO Next Week On Ozempic Price

(3/28, Madison Muller and Robert Langreth, Bloomberg) ...Senator Bernie Sanders wants to meet next week with Novo Nordisk A/S's top executive about lowering the price of its blockbuster drug Ozempic, fueling controversy over the costs of GLP-1 drugs for diabetes and obesity...A Novo spokesperson couldn't say whether its CEO would meet with Sanders. In a statement, the company said that "affordability challenges are real" for drugs and that it offers options to help US patients pay for medications. The company has said it's spending many billions of dollars to increase the supply of drugs like Ozempic... Full

Unintended Effects of Caps On Insulin Out-of-Pocket Costs

(3/28, Peter Wehrwein, Managed Healthcare Executive) ...Caps on out-of-pocket expenditures for insulin were not associated with increased use of insulin and had a limited effect on out-of-pocket costs for patients enrolled in the most common type of health plan, according to research results reported in the Annals of Internal Medicine this week. The unexpected results might give lawmakers and others pause as proposals to extend a monthly cap of $35 on insulin out-of-pocket expenses beyond Medicaregets debated in Congress and in policymaking circles... Full

The EPIC Act is a Cure for The Inflation Reduction Act's Health Care Mistake

(3/29, Sandip Shah and Krunal Patel, Northjersey.com) ...There's a reason they call New Jersey the "medicine chest to the world." Fourteen of the world's largest biopharmaceutical companies are here, as are 12 of the biggest medical technology firms. That makes us especially vulnerable to a provision in the 2022 Inflation Reduction Act that penalizes research on a broad category of drugs — with painful consequences for patients. There's a legislative fix in the works that could solve the problem, but it may not pass without the support of New Jersey legislators like Democratic Rep. Josh Gottheimer...A bipartisan piece of legislation now before Congress — the Ensuring Pathways for Innovative Cures, or EPIC, Act — could end this unintended consequence of the IRA. It would do so by simply giving both biologics and small-molecule drugs the same 13-year exemption... Full

Understanding the Politics of Drug Pricing in the United States

(3/28, Jonah Cornstock, Pharma Phorum) ...To help unpack some of those trends and conflicting perspectives, Brandon Newman, CEO of healthcare analytics firm Xevant, joins host Jonah Comstock on today's episode of the pharmaphorum podcast. They discuss the oft-maligned role of pharmacy benefit managers, problems with the drug pricing provisions in the Inflation Reduction Act, the lack of (and importance of) price transparency, the various levers available to the government to address prices, and what companies like Xevant are doing right now to lower drug prices for patients... Full

Hospitals Push Back On Child Site, Definition Reforms In Draft 340B Bill

(3/28, Gabrielle Wanneh, InsideHealthPolicy) ...Hospitals are generally supportive of the latest effort by Senate lawmakers to clarify Congress' intent and operational requirements for the 340B drug discount program...But hospitals are unenthusiastic about language in the draft legislation that would solidify a new definition of what constitutes a "patient" receiving discounted drugs through the 340B program, cement registration requirements for off-site facilities used by 340B hospitals and increase the reporting requirements for hospitals only, the American Hospital Association said in comments submitted to lawmakers Tuesday (March 26)... Sub. Req'd

PBMs Using 340B Program to Drive Profits at Patients' Expense

(3/28, Nicole Longo, PhRMA) ...PBMs aren't the only large corporations generating revenue from 340B. Nearly half of the Fortune 25 companies generate revenue from the 340B program, including PBMs, contract pharmacies, third-party administrators, health plans and wholesalers. Alarmingly, there are federal and state legislative proposals that would allow unfettered use of contract pharmacies — meaning PBMs would continue to siphon money from 340B without guardrails or oversight. This is especially concerning given hospitals' use of contract pharmacies is not improving access to medicines for patients. These proposals put the financial interests of for-profit corporations ahead of the needs of vulnerable patients... Full

Exclusive: China's WuXi AppTec Shared US Client's Data With Beijing, US Intelligence Officials Told Senators

(3/28, Michael Martina, Michael Erman and Karen Freifeld, Reuters) ...U.S. intelligence officials in late February told senators working on a biotech security bill that Chinese pharmaceutical firm WuXi AppTec had transferred U.S. intellectual property to Beijing without consent, according to two sources...A WuXi AppTec spokesperson said: "We are not aware of any unauthorized transfers by WuXi AppTec of any U.S. client's data or intellectual property to China. Safeguarding our customers' information is of the utmost importance to us, and we store it in keeping with their direction." WuXi AppTec "respects and fully complies" with the requirements of U.S. federal and state authorities, the spokesperson said... Full

Washington Wants to Avert Another Change Healthcare-Like Fiasco. Here's What Could Be Coming

(3/29, Mohana Ravindranath, STAT Plus) ...Washington is cracking down on the technology running behind the scenes in health care following a debilitating cyberattack on a health care payments processing company — and it could have major implications for hospitals and the vendors selling crucial IT...Still, it's not yet clear what will take hold in Washington: Experts tell STAT that it'll depend on the upcoming election, how fast federal regulators can get their act together, and the amount of lobbying pressure health trade groups exert to ensure they're not penalized for being attacked... Sub. Req'd

New OSP Director To Guide CDER-Wide IT Upgrades; System Enhancements Speed ANDA Assessments

(3/28, Derrick Gingery, Pink Sheet) ...The Generic Drug Structured Assessment for Bioequivalence (GDSA-BE) now is being used for two-way crossover in vivo pharmacokinetic BE studies in solid oral dosage form drug applications. The recently posted 2023 Office of Generic Drugs Annual Report states the move signaled the change from the narrative review to "structured data with dynamic, interactive, and integrated collaboration capabilities." The FDA told the Pink Sheet that GDSA-BE has been used for BE assessments in 40 ANDAs so far... Sub. Req'd

US FDA Drugs Center Ready To Break Down Silos On Regulatory Innovation

(3/28, Grace Moser, Pink Sheet) ...CDER Director Cavazzoni is promising to increase coordination and collaboration to accelerate broader adoption of innovative clinical trial designs and other approaches to speed drug development. A new "Quantitative Medicine Center of Excellence" illustrates the approach. The launch of a new Center of Excellence focused on modeling and simulation reflects a broader effort by the US Food and Drug Administration's drugs center to institutionalize innovative approaches to support drug development and regulatory decisions... Sub. Req'd

New WA Law Caps the Cost of Inhalers and EpiPens

(3/28, The Columbian) ...House Bill 1979, which passed both the House and the Senate unanimously, caps the cost of asthma inhalers and epinephrine autoinjectors for patients who have insurance that requires the patient to make co-payments or meet a deductible according to the bill's official summary. The maximum cost that can be incurred is $35 for a 30-day supply of inhalers or for a two-pack of autoinjectors...The bill goes into effect June 5... Full

Colorado Price Cap Plan For Enbrel Draws Amgen Lawsuit; Cosentyx, Stelara ‘Affordability' Reviews Pending

(3/28, Cathy Kelly, Pink Sheet) ...Amgen is suing to overturn the Colorado law that established and empowered the prescription drug affordability board. Enbrel would be the first drug to have an upper payment limit imposed by such a state board. Colorado's PDAB also selected Genvoya, Trikafta, Stelara and Cosentyx for affordability reviews and possible upper payment limits. The board has determined Genvoya and Trikafta are 'not unaffordable' and deliberations on Stelara and Cosentyx are ongoing... Sub. Req'd

20 Prescription Drugs On Colorado's Affordability Radar

(3/28, Lanie Lee Cook, FOX 31) ...The Colorado board created to review prescription drug prices is headed to court after it moved to cap the price of arthritis medication Enbrel — and it's not the only drug on the board's radar...The board's most recent report from October listed 604 drugs eligible for an affordability review. Some 244 were prioritized on a weighted scale based on the number of patients, the change in wholesale acquisition cost, patient out-of-pocket cost, total paid and average paid per person per year. The list is neither binding nor required by law and is instead "meant to be a tool to present data and spark discussion," according to the board... Full

Essential Medicines to Cost Slightly More from April 1; Here's Why

(3/29, Business Today) ..."Based on the WPI data provided by the office of the Economic Advisor, Department of Industry and Internal trade Ministry of Commerce and Industry, the annual change in WPI works out as (+) 0.00551% during the calendar year 2023 over the corresponding period in 2022," said NPPA...The new prices will cover more than 800 drugs on the list, including drugs like paracetamol, azithromycin, vitamins, minerals, some drugs to combat COVID-19, and steroids are on the list... Full

Japan Grants Global-First Approval To Zolbetuximab, 15 Other New Drugs

(3/29, Lisa Takagi, Pink Sheet) ...Japan announced its latest batch of drug approvals on March 26,, including a global-first approval for Astellas Pharma, Inc.'s Vyloy (zolbetuximab), a first-in-class anti-claudin (CLDN) 18.2 antibody, for the treatment of gastric cancer. The 30 new approvals included 16 drugs new to the Japanese market, along with multiple new indications and line extensions (see table below). Chugai Pharmaceutical Co., Ltd./Roche Holding AG's C5-inhibiting recycling monoclonal antibody Piasky (crovalimab) obtained its second approval globally after China in February, for paroxysmal nocturnal hemoglobinuria... Sub. Req'd

Note: Article links may expire over time or require a free registration. All news articles are the property of their respective publishers and copyright holders. [contextual emphasis added].

Teva global subscription access: Registration is required to access FirstWord and Generics Bulletin. Click on the links below to register. If you have any questions or issues with access, contact InfoNOW or visit InfoNOW's Industry News page for more details regarding these subscriptions.

                                                         

FirstWord Pharma Plus: Enter your work email address on the Registration page along with your contact information in order to receive access.

  

Generics Bulletin by Informa:

•      Registration: Click on "Sign In" (link on the upper right side of the page). Enter your work email address in the "username" box and press the "Tab" button on your keyboard or click out of the box. You will then be automatically logged into the Informa news resource (no password required). You may be redirected to the Account Settings page to update your contact information.                                

•       Subsequent Access: If you're not automatically logged in, click on "Sign In" (link on the upper right side of the page). Enter your work email address. You will be automatically logged in (no password is required).

•      Note: You must be on the Teva Network (in a Teva location or connected via VPN) in order to access the Informa news resources. You can toggle between the Informa news resources by clicking the news resource on the top.