Monday, April 8, 2024

Teva Presents Eight Studies from LAI Schizophrenia Research Program

(3/7, The Fly) ...Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries, announced the presentation of eight studies from its LAI schizophrenia research program, including data evaluating UZEDY, an extended-release injectable suspension of risperidone for subcutaneous use every one or two months for the treatment of schizophrenia in adults... Full

Duo Falter Again On US Belbuca ANDA, Eight Years After Joining Hands

(3/8, Dean Rudge, Generics Bulletin) ...Teva has yet to receive tentative approval for its proposed Belbuca generic and has relinquished first-to-file status, Jefferies noted, strengthening its case against the firm by observing that the company was also looking hesitant on its approach to another of Collegium's opioids, Nucynta (tapentadol) extended-release tablets...Meanwhile, according to Jefferies, Collegium did not think Teva had so far secured an authorized generic partner "and hasn't seen signs of scaling manufacturing." "At a minimum, this seems to indicate Teva's current plans for a generic Nucynta ER are unclear," Jefferies noted... Global Sub. Full

Report Warns of Crisis As Europe's Generic Medicines Reduced

(3/7, Laboratory News) ...Teva Pharmaceuticals, which ranks as the world's largest generic drug manufacturer, claims in its research that the number of generic medicines withdrawn from the market has surged by 12%, while the launch of new generic products has decreased by an average of 3% annually...Teva's study, The Critical Medicines Health Check', warns of escalating health challenges across Europe, citing antimicrobial resistance and adding the region now has 31% fewer antibiotic medicines than a decade ago, with a serious 21% decline in children's antibiotic syrups... Full

Price Caps On Asthma Inhalers a Big Win, But Barriers Remain

(3/6, Wendy Mondello, Allergic Living) ...Asthma advocacy groups are applauding the move by major pharmaceutical companies to cap the price of their respiratory inhalers...The action is especially welcome because asthma patients tend to ration or discontinue using medication because of high costs, says Kenneth Mendez, president and CEO of the nonprofit Asthma and Allergy Foundation of America. "Our research tells us the high cost of inhalers is the primary barrier to treatment," Mendez told Allergic Living. The decision to make inhalers more affordable comes after lawmakers criticized the three pharmaceutical companies, along with Teva Pharmaceuticals, for high inhaler costs. Teva, which has not announced a price cap, did not respond to a request for comment... Full

ACI Paragraph IV Disputes Conference

(3/6, Patent Docs) ...This year's conference co-chairs include Andrei Iancu (Partner, Sullivan & Cromwell LLP and former Director of the USPTO), Brian Malkin (Associate General Counsel, Teva Pharmaceuticals), and Mira Mulvaney (Assistant General Patent Counsel, IP Litigation, Eli Lilly & Company)... Full

Lupin Gets USFDA Nod for its Drug to Treat Movement Disorders

(3/8, Financial Express) ...Global pharma major Lupin Limited on Monday announced that it has received approval from the United States Food and Drug Administration for its Abbreviated New Drug Application for Valbenazine Capsules, 40 mg and 80 mg... Full

BMS' Newly Acquired Schizophrenia Drug Showed Continued Symptom Improvement in Open-Label Studies

(3/6, Max Bayer, Fierce Biotech) ...Bristol Myers Squibb's recently acquired schizophrenia drug demonstrated persistent symptom improvement without patients gaining weight, according to new long-term data, bolstering excitement around the prospect less than six months before the FDA will decide on its fate... Full

Phase 3 Comparative Clinical Study of Prolia® and Xgeva® (Denosumab) Biosimilar Candidate HLX14 Met Primary Endpoints

(3/8, Organon) ...Shanghai Henlius Biotech, Inc. and Organon announced that the phase 3 comparative clinical trial for the investigational Prolia® and Xgeva® (denosumab) biosimilar HLX14 met the primary endpoints. In 2022, Henlius entered into a license and supply agreement with Organon for the exclusive commercialization rights to two biosimilar candidates, including HLX14. The agreement covers markets such as the United States, the European Union, and Canada. An exception to the agreement is China... Full

Celltrion Secures Major PBM Contract for Zymfentra in the US

(3/8, Kim Chan-hyuk, Korea Biomedical Review) ...Celltrion said it has completed a registration contract for its subcutaneous Remicade biosimilar, Zymfentra (infliximab), with one of the top three pharmaceutical benefit managers in the United States. "We are pleased to announce through our website that we have successfully closed a deal with one of the top three PBMs in the US, resulting in Zymfentra's inclusion in their formulary," Celltrion said on its website on Monday. However, due to the contractual obligations, the company did not disclose the name of the PBM... Full

Sanofi to Cut Jobs in Pipeline Restructuring

(3/5, Nicole DeFeudis, Endpoints News) ...Sanofi's "new chapter" will involve job cuts and scrapping several oncology research projects, a spokesperson confirmed to Endpoints News on Friday. The pharma giant is conducting a "full pipeline reprioritization project," according to an internal email obtained by Fierce Biotech. Sanofi declined a request by Endpoints to explain which programs are being cut, how many jobs will be affected or when the changes will occur. The changes are part of CEO Paul Hudson's previously announced plans to become an "immunology powerhouse" as the company prepares for Dupixent's loss of exclusivity... Full

Bausch Health Sues Amneal Over IBS Treatment Patent

(3/5, Ben Glickman, Dow Jones) ...Bausch Health Companies said late Friday that it had filed a suit against Amneal Pharmaceuticals, a bid to stop the sale of a new generic version of Bausch's Xifaxan drug. The Canadian pharmaceutical company said Amneal had filed an abbreviated new drug application with regulators, seeking approval to market a generic version of the irritable bowel syndrome treatment... Sub. Req'd

American Airlines, Target, Others Sue Drugmakers Over Alleged Price-Fixing

(3/5, MT Newswires) ...American Airlines Group, Target and several other major employers filed a lawsuit in a federal court alleging several pharmaceuticals making generic drugs of orchestrating a price-fixing that led to increases in drug prices since 2009. The lawsuit, filed in the US District Court for the Eastern District of Pennsylvania on Thursday, alleges that the defendants, including Pfizer and Novartis, also engaged in unlawful activities such as bid rigging, and market allocation of hundreds of generic drugs... Full

‘Speculation Is Not Science': Lupin Breezes Past Galderma On US Oracea Patents

(3/5, Dean Rudge, Generics Bulletin) ...A US district court in Delaware has scolded Galderma, telling the firm that it had "a theory but no proof," as it firmly rejected the originator's infringement claim against Lupin over two US patents shielding the Oracea (doxycycline) modified-release capsule treatment for rosacea. In response, Galderma has filed an immediate appeal to the US Court of Appeals for the Federal Circuit... Global Sub. Full

Biocon Leads Generic Race for Blockbuster Weight Loss Drugs as Patents Set to Expire Soon

(3/8, Financial Express) ...Biocon is reportedly a step ahead of its competitors with the UK approval for the first generic version of liraglutide injectible, which is losing patent protection in November this year, Bloomberg reported. The weight loss drug which is sold under the brand name Saxenda by patent holder Novo Nordisk A/S, is among the first of the groundbreaking medications in this category to lose patent protection... Full

Aurobindo Pharma Arm Gets 3 Observations from US FDA After Andhra Unit Inspection

(3/5, Jomy Jos Pullokaran, CNBC TV 18) ...Aurobindo Pharma Ltd on Friday (April 5) said the United States Food and Drug Administration has conducted an inspection of its newly operational injectable facility in Andhra Pradesh...According to Aurobindo Pharma, the observations made by the US FDA are procedural in nature and will be addressed within the stipulated timeframe... Full

Strides Pharma's Chennai Facility Gets 2 Observations

(3/8, Business Standard) ...Strides Alathur is a wholly owned subsidiary of Strides Pharma Science. The inspection closed with two observations. The drug maker informed that it will respond to these observations comprehensively to US FDA within the stipulated time... Full

Big Pharma Stocks Need a Rethink. Investors Keep Making the Same Mistake.

(3/4, Josh Nathan-Kazis, Barron's) ...Most Big Pharma stocks have struggled in recent years. Decades of efforts by these companies haven't changed a fundamental truth: Drugmakers eventually lose exclusive rights to their best inventions. Think of rivals being allowed to sell perfect clones of Apple's iPhone, or McDonald's having to share its Golden Arches. New laws allowing Medicare to negotiate the prices it pays for some medicines-before patents expire-only exacerbates the issue... Full

Change Healthcare Attack Sheds Light On Industry's Weak Points

(3/8, Tina Reed, Axios) ...The expansive impact of the Change Healthcare cyberattack was a wake-up call for a health care system that's now racing to safeguard itself against another industry-rattling hack...Some experts said the federal government quickly needs to do a sectorwide accounting to understand where health care's biggest systemic cyber risks are and address them - before hackers beat them to it... Full

US Drugs with Noted Supply-Chain Risks 5 Times More Likely to Go into Shortage in Early COVID

(3/5, Mary Van Beusekom, MS, CIDRAP) ...In the first few months of the COVID-19 pandemic, US prescription drugs flagged for potential supply-chain disruptions were nearly five times more likely to go into shortage than those without such warnings, finds a University of Pittsburgh-led study..."Ongoing policy work is needed to protect US drug supplies from future shocks and to prioritize clinically valuable drugs at greatest shortage risk," the researchers wrote... Full

Veteran Prescriptions for Addictive ADHD Drugs Are Not Being Properly Vetted and Tracked, Watchdog Says

(3/5, Kelsey Baker, Military.com) ...Department of Veterans Affairs prescriptions for attention-deficit/hyperactivity disorder, more commonly known as ADHD, should be made tougher to obtain in the future, according to a new report by the VA inspector general. The inspector general found that VA providers aren't always documenting patient assessments before prescribing the stimulant drugs used to treat ADHD, such as brand-name drugs Adderall and Ritalin. In some cases, they are relying on the patient's self-reporting without even conducting an assessment... Full

Universities, Including Penn, Say Biden Tactic to Lower Drug Prices May Stifle Innovation

(3/8, Harold Brubaker, The Philadelphia Inquirer) ...The University of Pennsylvania and top research universities nationwide say a Biden administration proposal could make it harder, and possibly less lucrative, to license faculty inventions developed with government funding for research...Penn says the new guidance would stifle commercialization efforts that have made the Philadelphia region a strong player in the development of new cell and gene therapies. Penn scientists developed a technology underlying the most common COVID-19 vaccines, resulting in more than a $1 billion in royalties for the university from licensing agreements... Full

Attacks On Pharmacy Benefit Mgrs. Won't Reduce Drug Prices

(3/8, Ike Brannon, RealClearMarkets) ...At the federal level, a primary target for PBM criticism is the fact that PBMs negotiate rebates rather than discounts, as the Robinson-Patman Act effectively prohibits the latter. Rather than amend the law to allow up-front, volume-based discounts, misguided anti-PBM proposals would instead mandate that all rebates be passed onto the health plan sponsor. Such a provision is largely, as most rebates do end up beginning passed through. Proposed legislation would also prohibit PBMs from having their revenue tied to the size of the rebate obtained, which would impact the incentives of PBMs to negotiate discounts altogether... Full

CMS Allows Part D Plans To Substitute All Biosimilars

(3/5, Gabrielle Wanneh, InsideHealthPolicy) ...Medicare Part D plan sponsors are now permitted to immediately substitute all FDA-approved biosimilars, not just those deemed "interchangeable" by FDA, as formulary "maintenance changes," CMS announced as part of its final calendar year 2025 Medicare Advantage and Part D final rule Thursday (April 4)... Sub. Req'd

Biosimilar Substitution In Medicare Part D Formularies Mid-Year Established In Final Rule

(3/5, Cathy Kelly, Pink Sheet) ...Despite skepticism expressed in some stakeholder comments, CMS maintained the biosimilar substitution policy is important to promote uptake of follow-ons, and may save money down the road, though the rule does not predict savings to the Medicare Trust Fund. The comments pointed out, among other things, that allowing mid-year substitutions for non-interchangeable biosimilars could reduce incentives to develop interchangeable products. The Administration is showing signs that it believes interchangeability is overrated... Sub. Req'd

PCMA Releases Statement On CMS Part D Biosimilar Substitution Announcement

(3/5, PCMA) ..."PCMA applauds CMS' decision to grant Medicare Part D plans and PBMs the flexibility to substitute any lower-cost, therapeutically equivalent biosimilar in place of a high-cost brand name reference biologic without the need for additional permissions and notifications. Pharmacy benefit companies are strong proponents of a robust biosimilar market and have advocated for policy changes like this that will unlock the potential of biosimilars by increasing uptake and put an end to brand manufacturers' tactics to extend exclusivity on brand-name biologics."... Full

HHS 'Misses the Mark' in Drug Shortage Proposal, ASHP Says

(3/5, Paige Twenter, Becker's Hospital Review) ...The American Society of Health-System Pharmacists partly welcomed HHS' 18-page policy recommendations for drug shortage strategies, but the organization said it "proposes concerning penalties."...In an April 3 statement, the ASHP said it was satisfied to see many of its recommendations included in the proposal, but it "misses the mark by suggesting penalties against hospitals that do not adopt HHS-required inventory and purchasing practices."... Full

FDA Draft Guidance Urges Quality Controls In BA/BE Studies, Fraud Reporting

(3/5, Jessica Karins, InsideHealthPolicy) ...FDA has published draft guidance calling on generic drug applicants conducting bioavailability or bioequivalence (BA/BE) studies to take more precautions in protecting data integrity, including maintaining accessible records and creating a quality culture, coming shortly after Congress' investigative arm warned regulatory loopholes surrounding the studies are hamstringing FDA's enforcement efforts. The guidance encourages anyone who identifies potential evidence of fraud, manipulation or mismanagement of BA/BE data to report concerns to FDA... Sub. Req'd

House Committee to Press FDA Commissioner Robert Califf On Shortage Oversight, Other Issues

(3/5, Zoey Becker, Fierce Pharma) ...Amid ongoing drug shortages and other headline-grabbing issues that fall under the FDA's purview, the House Committee on Oversight and Accountability is putting the agency's commissioner Robert Califf, M.D., on the hot seat...Through several investigations, the oversight committee has "identified how dysfunction at the FDA could be worsening many of these preventable crises," Comer noted in the statement. Califf will face questions about what the agency is doing to address the issues and how it's conducting plant inspections to prevent similar supply shortfalls going forward... Full

Califf To Testify At House Oversight On Drug Shortages, Hemp, Food Safety

(3/5, Jessica Karins, InsideHealthPolicy) ...FDA Commissioner Robert Califf is set to testify next Thursday (April 11) before the House Committee on Oversight & Accountability on issues including drug shortages, drug facility inspections, food safety, and regulation of products like hemp, tobacco and nicotine, and over-the-counter decongestants... Sub. Req'd

OPQ's 2023 Annual Report: an Upbeat Review of CDER's Quality Efforts

(3/8, John W.M. Claud, FDA Law Blog) ...This year's report noted that CDER's Drug Product Catalog contains over 140,000 entries, the same amount as OPQ listed in 2022. Readers also saw that that the Center's manufacturing Site Catalog remains steady at more than 4,800 entries, the same number we found in the 2022 State of Pharmaceutical Quality report...Drug shortages have been a scourge for FDA, both as they negatively affect consumers and FDA's reputation. The report stated that OPQ performed 359 expedited quality assessments to address shortages... Full

New Online Portal Lets Companies Track UK Drug Filings More Easily

(3/5, Eliza Slawther, Pink Sheet) ...Companies that have applied for a drug marketing authorization or label variation in the UK can now check the status of their applications online, through the MHRA's newly-launched RegulatoryConnect portal. According to the MHRA, the new portal provides "greater transparency and visibility for regulatory assessments for industry." At present, the portal enables companies to view live authorization details and track the application status for a filing without needing to contact the MHRA itself... Sub. Req'd

PRIME Scheme: EMA Says Yes To Hookipa, Bluejay & 89bio But No To Six Others

(3/5, Neena Birzmohun, Pink Sheet) ...Esepapogene zalarnarepvec, BJT-778 and pegozafermin are the latest investigational products that the European Medicines Agency said merited a place on its priority medicines scheme...All three products were accepted onto PRIME last month, bringing to six the total number of drugs that managed to secure a place on the scheme in the first quarter of 2024. Drugs are accepted onto PRIME sparingly and only the most promising ones make it – they must be shown to have the potential to benefit patients with unmet medical needs based on early clinical data... Sub. Req'd

How to Revolutionise Research and Innovation in India's Pharma and Medtech Sectors

(3/6, Arvind Sharma, CNBC TV 18) ...Cutting-edge technologies such as artificial intelligence (AI), machine learning (ML), big data analytics and genomics are transforming the landscape of research and development in India's pharmaceuticals and MedTech sectors, and such technologies can also speed up drug discovery, bringing about innovative tools for diagnosis, treatment, and patient care, writes Arvind Sharma and Pallavi Mall of Shardul Amarchand Mangaldas & Co... Full

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