Friday, May 31, 2024

FDA Approves Deutetrabenazine Once Pill Extended-Release Tablets to Treat TD and HD Chorea

(5/30, Gillian McGovern, Pharmacy Times) ...The FDA has approved deutetrabenazine (Austedo XR; Teva Pharmaceuticals) as an oral, once daily, extended-release treatment option indicated for adults with tardive dyskinesia and Huntington disease chorea. The treatment now has 4 different doses, including 30-, 36-, 42-, and 48-mg tablets... Full

FDA Approves More Austedo XR One-Pill-A-Day Tablets

(5/30, Marisa Wexler, MS, Huntington's Disease News) ...The U.S. Food and Drug Administration has authorized new dosage strengths of Austedo XR (deutetrabenazine) extended-release tablets for managing chorea, or involuntary movements, in adults with Huntington's disease...According to Teva, about 90% of patients with insurance coverage can expect to pay $10 or less for each prescription of Austedo XR with financial assistance offerings. Through its Shared Solutions service, the company provides support with access and reimbursement of Austedo XR and Austedo, in addition to patient assistance... Full

Austedo XR Approved: A New Treatment Option for Tardive Dyskinesia and Huntington Disease

(5/30, Leah Kuntz, Psychiatric Times) ...The US Food and Drug Administration has approved Teva Pharmaceuticals' Austedo XR (deutetrabenazine) as a once-daily pill treatment option, available in 4 new tablet strengths (30, 36, 42, 48 mg), indicated in adults for tardive dyskinesia and Huntington disease chorea control..."This latest Austedo XR approval provides patients with the same proven efficacy, but now with the convenience of a one pill, once-daily option for clinically therapeutic doses as established by the pivotal clinical trials to help control involuntary movements that can make carrying out basic daily activities difficult, [said Rakesh Jain, MD, clinical professor of Psychiatry, Texas Tech University School of Medicine]."... Full

Who's Hired? Dr Reddy's Names New North America Chief

(5/30, David Wallace, Generics Bulletin) ...A busy couple of weeks for executive appointments in the generics and biosimilars industry has seen Dr Reddy's name a new North American CEO, Fresenius Kabi appoint a new biopharma chief, Teva recruit a new head of global operations, and more...Teva has named Matthew Shields as executive vice-president for Teva Global Operations, the firm's manufacturing and supply division. Reporting directly to Teva president and CEO Richard Francis, Shields will be based in Teva's US headquarters in Parsippany, New Jersey... Global Sub. Full

Amgen Snatches First FDA Approval For Soliris Biosimilar

(5/30, Urte Fultinaviciute, Generics Bulletin) ...Amgen has established its frontrunner position in the eculizumab race with a recent FDA approval and an interchangeability designation...Bkemv is expected to enter the US market in March 2025, two years before various Soliris patents expire. This was made possible after Amgen in 2020 reached a settlement with Alexion in patent litigation proceedings... Global Sub. Full

Verona's Ensifentrine Will Be a 'Paradigm Shift in COPD Treatment,' GlobalData Says

(5/30, Kevin Dunleavy, Fierce Pharma) ...Coming in under the radar with its own formidable COPD candidate is London-based Verona Pharmaceuticals. Ensifentrine—which has a PDUFA date of June 26, one day ahead of that for Dupixent—might be poised to upstage its powerhouse rival in the indication, according to positive reports from two industry think tanks on Thursday. Based on data Verona presented earlier this month at the American Thoracic Society international conference, GlobalData has called ensifentrine a "paradigm shift in COPD treatment."... Full

FDA Delays Dupixent in COPD Decision by Three Months While EMA Gives Thumbs Up

(5/31, Amber Tong, Endpoints News) ...Sanofi and Regeneron will have to wait three more months for a major FDA decision on expanding Dupixent's label, the companies disclosed Friday morning. Meanwhile, European authorities have recommended its approval in the same indication...The deadline is now pushed from June 27 to Sept. 27. In a statement, Sanofi and Regeneron emphasized that the FDA "did not raise any concerns regarding the approvability of Dupixent for this indication," and that they remain confident that the additional analyses "strongly support" approval... Full

US FDA Approves Use of Bristol's Cell Therapy for Rare Blood Cancer

(5/30, Bhanvi Satija and Sneha S K, Reuters) ...Bristol Myers Squibb, said on Thursday the U.S. FDA had allowed expanded use of its cell therapy for an aggressive and rare type of blood cancer, making it the third approval for the treatment this year...The expanded approval for Bristol's drug is based on data from a study that showed it helped clear all signs of cancer in 67.6% of MCL patients who had previously received two or more treatments... Full

FDA Approves Liso-Cel to Treat R/R Mantle Cell Lymphoma

(5/30, AJMC) ..."Mantle cell lymphoma is a very complex disease, because it's an incurable disease, but also because there are a variety of treatment options and treatment strategies," Christopher Flowers, MD, division head in the Division of Cancer Medicine at MD Anderson Cancer Center, and chair and professor of the Department of Lymphoma/Myeloma at The University of Texas MD Anderson Cancer Center, told The American Journal of Managed Care® in an interview...Bristol Myers Squibb, the maker of liso-cel highlighted the administration of the treatment in both the inpatient and outpatient setting in the TRANSCEND NHL 001 trial. According to Flowers, that is an important component of making liso-cel accessible for more patients... Full

European Commission Grants Marketing Approval to Biogen's ALS Drug

(5/30, Sneha S K, Reuters) ...Biogen said on Thursday that the European Commission has granted marketing authorization under exceptional circumstances for its amyotrophic lateral sclerosis drug Qalsody. The approval is based on a 108-patient trial that showed Qalsody reduced levels of a neurofilament protein that scientists believe is tied with the disease's progression... Full

Sun Pharma, Dr Reddy's Pull Drugs in US Over Manufacturing Issues: USFDA

(5/30, Press Trust Of India) ...In its latest Enforcement Report, the US health regulator stated that a US-based unit of Sun Pharma is recalling 35,069 bottles of medication used to treat high pressure inside the eye due to glaucoma or other eye diseases. New Jersey-based Sun Pharmaceutical Industries Inc is recalling the affected lot of Xelpros (latanoprost ophthalmic emulsion) due to "out of specification for particulate matter test"... Full

Amid Chemo Shortages, Sagent Recalls 2 Lots of Docetaxel Over Particulate Concerns

(5/30, Zoey Becker, Fierce Pharma) ...Amid a shortage of standard-of-care chemotherapy drugs, Sagent Pharmaceuticals is pulling two lots of its docetaxel injection from U.S. shelves after receiving a report of potential particulate matter in a vial... Full

Drug Treatment That Insists On Abstinence? Federal Agencies Are Just Saying No

(5/31, Lev Facher, STAT) ...In public statements, official agency guidance, new regulations, and even in instructions to pharmaceutical companies about how to develop new addiction treatments, the federal government is increasingly making clear that, even if abstinence isn't possible, it welcomes a secondary and often similarly meaningful endpoint: simply reducing use... Full

Mark Cuban Cost Plus Drug and TranspareRx Team Up to Help Patients Compare Insurance to Best Savings & Lowest Rx Prices

(5/30, TranspareRx Corporation) ...TranspareRx Corporation, a leading healthcare technology company that developed the next-generation prescription savings platforms, Cuverd and TextRx, announced today its collaboration with Mark Cuban Cost Plus Drug Company, PBC. The integration of Cost Plus Drugs' pricing into Cuverd and TextRx makes it easier for patients and employees to access and afford their prescribed medications... Full

Taxpayer Advocates Slam Biden, Trump-Era Approaches To Drug Pricing

(5/30, Gabrielle Wanneh, InsideHealthPolicy) ...A nonpartisan taxpayer advocacy group is calling on federal lawmakers to redirect their efforts to lower prescription drug costs away from further implementing price controls under the Inflation Reduction Act or revisiting a Trump-era policy that tied the prices of drugs reimbursed under Medicare Part B to prices paid by foreign countries. Rather, the group says Congress should get pharmacy benefit manager market reforms over the finish line and consider updating the federal drug discount program, among other recommendations... Sub. Req'd

AAM Submits Comments to HHS and FTC On the Impact of GPOs and Wholesalers On Access to Generic Medicines

(5/30, AAM) ......"The sustainability of competitive generic and biosimilar markets and the continuing supply of Food and Drug Administration approved/licensed generic and biosimilar medicines for patients, uninterrupted by shortages, is in jeopardy," said David Gaugh, Interim President and CEO of AAM. "Although generic and biosimilar manufacturers have contributed to dramatically lower rates of health care spending, their ability to continue to provide affordable medicines is threatened by excessive consolidation of intermediary participants - group purchasing organizations (at both the retail and hospital levels), wholesalers, and pharmacy benefit managers... Full

Biosimilars Council Calls for More Efficient Regulatory Pathways for Critical Medicines

(5/30, Biosimilars Council) ..."The time is now to update and streamline the current regulatory model for biosimilars," said Craig Burton, Executive Director for the Biosimilars Council. "Around 80 percent of biologics currently do not have a biosimilar product in the works. Let's reduce that percentage and pave the way for a new generation of lower-cost medications."... Full

Senator Baldwin Hosts Roundtable Discussing the Prices of Inhalers

(5/30, Crystal Flintrop, WXOW) ...Senator Tammy Baldwin (D-WI) welcomed healthcare officials Thursday afternoon for a roundtable discussion. The conversations highlighted her efforts to help lower the cost of prescription medication, while holding big drug companies accountable. Thursday, she discussed the investigation into four of the largest inhaler manufacturers in the United States. The investigation resulted in three of the four to commit to capping out of pocket costs per month... Full

The U.S. Can Learn From Other Countries About Setting Drug Prices

(5/30, Kirsten Axelsen, RealClearHealth) ...The IRA allocated $3bn with little clarity into how that money should be spent, and CMS has a significant opportunity to reconsider the process in future years. In fact, CMS recently released draft guidance for the next year of the negotiation program and solicited feedback on a number of issues. This creates an opportunity to learn from the mistakes made by other countries and revise the process to be more predictable and responsive to the outcomes that matter to people who depend on the Medicare program... Full

Wenstrup Will Aim To Add BIOSECURE Act To NDAA Bill

(5/30, Maaisha Osman, InsideHealthPolicy) ...The BIOSECURE Act, a bill that would bar American companies from working with some foreign-owned biotechnology companies, will likely be introduced as an amendment to the National Defense Authorization Act, a spokesperson for Rep. Brad Wenstrup (R-OH), one of the authors of the biotech security bill, tells Inside Health Policy. "It is our hope that the BIOSECURE Act will be added as an amendment to the NDAA," Wenstrup's spokesperson said Wednesday (May 29)... Sub. Req'd

The Future of Visual Inspection

(5/30, Tracey Sinjen, Lachman Consultants) ...Overall, the integration of AI into automated visual inspection systems marks a significant advancement in enhancing product quality, operational efficiency, and regulatory compliance within the pharmaceutical manufacturing sector. As technology continues to evolve and best practices are refined, AI is poised to play a pivotal role in driving continuous improvement and innovation in quality control processes... Full

FDA to Begin Restructuring its Inspection Office in October

(5/30, Anna Brown, Endpoints News) ...As part of the restructuring, which will begin Oct. 1, the Office of Regulatory Affairs, which previously housed all of the FDA's drug and biologics inspectors, will now be called the Office of Inspections and Investigations (OII) to emphasize its "role as the frontline of the FDA," according to an agency press release on Thursday... Full

Novartis Sues Maryland Over Pharmacy Law On Drug Discount Limits

(5/30, Nyah Phengsitthy, Bloomberg Law) ...Novartis in the US District Court for the District of Maryland is suing the state over its recently enacted law (H.B. 1056) requiring manufacturers in the 340B Drug Pricing Program to deliver discounted drugs to pharmacies that contract with providers in the program... Sub. Req'd

Novartis Sues Maryland Over the Role of Contract Pharmacies in a U.S. Drug Discount Program

(5/30, Ed Silverman, STAT Plus) ...The drugmaker maintained that the state law, which goes into effect on July 1, improperly forces pharmaceutical companies to supply so-called contract pharmacies as part of the discount program known as 340B, according to the lawsuit filed in federal court. Novartis argued the law is illegal because it is preempted by federal law and also violates the U.S. Constitution... Sub. Req'd

EU Health Union Has Promise to Deliver On Equitable Access to Medicines

(5/30, Medicines for Europe) ...Commenting on the establishment of the European Health Union, Adrian van den Hoven, Director General of Medicines for Europe said "The EU Health Union was built on some of the very hard learned lessons during the EU response to Covid-19. We commend this initiative and call on the EU to level up it, by improving equitable and timely access to medicines for those who need it most in the Pharma review. Through the Critical Medicines Alliance, we will work for a Critical Medicines Act to strengthen manufacturing and reduce shortages, which we hope to be prioritised in the first 100 days of the next Commission mandate."... Full

DREAMM Comeback Prompts GSK To Seek Fast-Track EMA Review For Blenrep

(5/30, Neena Brizmohun, Pink Sheet) ...The European Medicines Agency is this week deciding whether the planned EU filings for sipavibart, lifileucel and Blenrep – which was previously approved but withdrawn in the EU and the US – merit an accelerated assessment. GSK has asked the European Medicines Agency to fast track its planned EU marketing application for belantamab mafodotin, the company's multiple myeloma treatment that was approved in the EU and the US as Blenrep but then withdrawn from both markets following a confirmatory study failure... Sub. Req'd

Irish Body Calls For Urgent Action To Tackle Drug Shortages

(5/30, Adam Zamecnik, Generics Bulletin) ...Citing a recent Red C survey, Medicines for Ireland highlighted that 20% of Irish patients have been personally affected by medical shortages in the past two years. Additionally, 22% of respondents reported that their family members or friends have also been affected by such low stocks...To tackle such challenges, MFI suggests that regulators implement dynamic pricing policies, which could encourage competition. Additionally, new policies that incentivize the use of generic medicines, which would ensure greater access to affordable drugs, should also be adopted... Global Sub. Full

Domestic Drugmakers Call for Indo-US Collaboration to Ensure Supplies of Affordable Medicines

(5/30, PT Jyothi Datta, The Hindu BusinessLine) ...Domestic drugmakers are calling for an "affordable medicine" partnership between India and the US, to ensure a secure and sustainable pharmaceutical supply chain. Indian drugmakers already carry the legacy of being a pharmacy to the world, but the Indian Pharmaceutical Alliance seeks to expand collaboration between the two countries, in a formalised manner, possibly as a preferred partner. This would facilitate an enhanced and resilient trade, involving more products between the two countries, a person familiar with the development said, pointing to medicine shortages the US grapples with... Full

Pharma Exports to Grow at a Faster Clip, Touch $31 Billion in FY25

(5/30, N. Ravi Kumar, The Hindu) ...India's pharmaceutical exports are expected to grow over 11% and touch record $31 billion in FY25 on the back of multiple factors, especially a shortage of drugs in the key U.S. market, a top official of the exporters body under the Commerce Ministry said on Thursday. For the fiscal ended March 2024, pharma exports, a mainstay in the country's global trade, rose 9.6% to $27.8 billion. The growth came amid numerous global challenges, Pharmaceuticals Export Promotion Council of India Director General Ravi Uday Bhaskar said... Full

Japanese Pharma's Neurology Focus Not Going Away

(5/30, The Pharma Letter) ...Globally, the devastating and widespread impact of neurological disorders like Alzheimer's disease, epilepsy, Parkinson's disease and depression is only getting worse. This is particularly true in the Asia-Pacific region, where prevalence is high, and access to treatment depends to a large extent on geography...To cater to the unmet need, a number of Japanese pharma companies have launched key assets... Sub. Req'd

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