Tuesday, July 9, 2024

Generic-Viagra Safety in Question After False Data Found by FDA

(7/9, Anna Edney, Bloomberg) ...The US Food and Drug Administration alerted brand-name and generic companies June 18 about a research company in India that had falsified the data used in key studies to gain approval of their medications. Data from the researcher, Synapse Labs Pvt. Ltd., may have been used in hundreds of drugs, which remain available for sale on pharmacy shelves and in Americans' medicine cabinets...The FDA said companies that used Synapse will get a year to submit new data on the drugs... Full

Sandoz And Just-Evotec Expand Biosimilars Collaboration

(7/8, David Wallace, Generics Bulletin) ...Just-Evotec Biologics has announced that it will be expanding a partnership struck with Sandoz in 2023 to develop and manufacture biosimilars, potentially adding further biosimilars to the pair's development pipeline and offering "further guarantees for Sandoz's long-term commercial supply security."... Global Sub. Full

Sun Pharma Open to Exploring Acquisitions in Global Specialty Portfolio

(7/8, Sohini Das, Business Standard) ...In the 2023-24 annual report, Chairman and Managing Director Dilip Shanghvi said: "Sun Pharma had a strong net cash position of approximately $2.4 billion, which enables us to explore inorganic opportunities, including but not limited to strengthening our global specialty portfolio." He added that the firm made critical hires in several functions, and the focus has been to improve in-house clinical development capabilities for which the firm is building a clinical organisation, globalising specialty assets beyond the US, and deepening business development capabilities... Full

Celltrion's Xolair Biosimilar Secures Approval in UK

(7/9, Lee Han-soo, Korea Biomedical Review) ...Celltrion said its Xolair biosimilar, Omlyclo (omalizumab), which was called CT-P39 in the developing stage, received approval from the U.K. Medicines and Healthcare products Regulatory Agency as the first biosimilar of its kind...The company plans to leverage its first-mover advantage to rapidly penetrate the UK market, offering a new treatment option for patients suffering from allergic conditions... Full

Roche Scores FDA Nod for Prefilled Syringe Version of Vabysmo, Easing its Administration

(7/8, Kevin Dunleavy, Fierce Pharma) ...Friday, Roche took another step in its advancement of the blockbuster medicine, scoring an FDA nod to provide it in a prefilled syringe. The 6-mg, single-dose shot will give doctors a simplified, ready-to-use alternative to extracting Vabysmo from a vial. Vabysmo PFS will be available later this year—along with its current 6-mg vial product—for the treatment's three indications. The FDA endorsed Vabysmo for wet-age macular degeneration and diabetic macular edema in January 2022 and followed with a nod for retinal vein occlusion nine months ago... Full

Alembic Pharma Gets USFDA Nod for Generic Bromfenac Ophthalmic Solution

(7/9, Press Trust Of India) ...Alembic Pharmaceuticals Ltd on Tuesday said it has received final approval from the US health regulator for its generic Bromfenac ophthalmic solution, which is indicated for the treatment of postoperative inflammation and pain in patients who have undergone cataract surgery... Full

To Improve Quality Standards, We Need to Build a Robust Culture: Sun Pharma's Dilip Shanghvi

(7/8, Naini Thaker, Forbes India) ...During the recent Indian Pharmaceutical Alliance's 9th edition of the Global Pharmaceutical Quality Summit 2024, [Sun Pharma, Managing Director Dilip] Shanghvi spoke about navigating supply chain challenges, creating a culture of quality and more... Full

Indivior Shares Dive On Profit Warning, Dropping of Schizophrenia Drug

(7/9, Radhika Anilkumar, Reuters) ...Drugmaker Indivior Plc slashed its 2024 profit forecast while signaling a slowdown in sales of its top-selling opioid addiction treatment, and said it would discontinue sales of its schizophrenia drug Perseris, prompting its shares to plunge 44% on Tuesday. Indivior's Sublocade drug has faced intense competition from the launch of a rival, as well as the end of pandemic-relief measures that has led to loss of coverage in the United States for some people enrolled in government-backed Medicaid plans... Full

Purdue Creditors Seek Approval to Sue Sackler Family Members

(7/8, Dietrich Knauth, Reuters) ...Purdue Pharma's creditors sought permission from a U.S. bankruptcy court on Monday to sue the company's wealthy owners, arguing that the litigation can serve as both a negotiating tool and a fallback option as the OxyContin maker re-starts talks on a bankruptcy settlement...A court-appointed committee of Purdue creditors, which includes individuals harmed by the opioid crisis as well as insurers and companies with opioid claims, said in a Monday court filing in White Plains, New York that they need the ability to sue to ensure that the Sacklers are not "allowed 'off the hook' for their grotesque misconduct in creating and fueling the opioid crisis."... Full

Study: Taxing Antibiotics Might Decelerate Drug-Resistance Crisis

(7/8, Anuradha Varanasi, Forbes) ...In a recent study, a group of economists found that taxing some antibiotics that are more profitable than others could be a highly effective measure to prevent doctors from over-prescribing those drugs and decelerate the ongoing antibiotic resistance crisis..."If the problem goes unchecked, as many as 10 million lives a year, and as much as $100 trillion output worldwide would be at risk by 2050," co-author Farasat Bokhari at Loughborough University and colleagues added... Full

Judge Shoots Down BI Lawsuit, Possibilities Dwindling For Remaining IRA Cases

(7/8, Gabrielle Wanneh, InsideHealthPolicy) ...A Connecticut district court judge last week rejected Boehringer Ingelheim's lawsuit against Medicare drug price negotiation, marking the fifth lawsuit against the Inflation Reduction Act program to be shot down at the district level, lessening the chances of the drug industry receiving a win that could potentially propel the issue to the Supreme Court... Sub. Req'd

With Boehringer Ruling, Industry Extends Legal Losing Streak Against Medicare Price Negotiations

(7/8, Eric Sagonowsky, Fierce Pharma) ...A spokesperson for BI said the company is "disappointed by this ruling and what it means for biopharmaceutical innovation." "Boehringer Ingelheim shares the goal of ensuring our medicines are affordable and available to people who need them—however, we remain concerned about the detrimental and limiting effects the IRA and its 'negotiation' program will have on the future of innovation for the patients we serve," the spokesperson added... Full

Drugmakers Are Losing Crucial Friends On Capitol Hill

(7/9, Rachel Cohrs Zhang, STAT Plus) ...Six key pharma-friendly lawmakers who were in office when Democrats passed a historic drug pricing reform law will likely have left Capitol Hill by the beginning of 2025, by STAT's count..."When you lose veterans who already understand those complex relationships, it makes it harder for whatever industry we're talking about to actually deliver a message that is received," former Rep. Billy Tauzin, who also served as CEO of the brand-drug lobby PhRMA, told STAT... Sub. Req'd

Gilead's HIV Drug Patent Battle with CDC Continues with Government Appeal

(7/8, Katherine Lewin, Endpoints News) ...The US government is appealing a jury's decision that granted Gilead a major win in a patent fight over the company's blockbuster HIV treatments Truvada and Descovy...The Delaware decision "upheld an earlier jury verdict in favor of Gilead that the U.S. government's patents are invalid," Gilead told Endpoints News in an emailed statement on Monday. "The Court's decision and jury verdict recognized Gilead's commitment to transforming the lives of the communities we serve." Gilead said it will continue to work with HHS and the CDC "toward our common goal to end the HIV epidemic for everyone, everywhere."... Full

The Future of Oncology R&D Lies in Policymakers' Hands

(7/8, Lori Reilly, PhRMA) ...I recently spoke at The Atlantic's People v. Cancer with Daniel Asch, Vice President of the Oncology Franchise at Boehringer Ingelheim, to discuss the progress we are making to deliver precision medicine in oncology and how it can greatly improve outcomes for cancer patients. Dan and I also examined the policy reforms needed at the federal level to safeguard the future of these remarkable therapies and ensure that they reach the patients who need them most... Full

NCPA Launches Powerful New TV Ad: "PBM Career Day"

(7/8, National Community Pharmacists Association) ...The ad, entitled "PBM Career Day," highlights the position PBMs have carved out for themselves as drug middlemen and their illogical and confusing role in health care. As a PBM executive struggles to explain his job to curious children, he reveals that he doesn't make, prescribe, or provide drugs - but he does decide what prescriptions patients can receive and what they'll pay for them... Full

House Speaker Plans Vote On Biosecure Act as Part of China Legislation Push

(7/9, Jared Whitlock, Endpoints News) ...House Speaker Mike Johnson (R-LA) on Monday pledged a vote this year on a bill targeting Chinese biotech contractors, providing fresh momentum to the legislation...Under the bill, US firms would have until 2032 to stop contracting with "companies of concern" such as WuXi AppTec, WuXi Biologics and BGI. Despite that grace period, drugmakers still face uncertainty in switching from popular WuXi services. "We will vote on the Biosecure Act, which will halt federal contracts with biotech companies that are beholden to adversaries," Johnson said... Full

FDA Reg Agenda Places NPRM On Recalls In December 2024

(7/8, Jessica Karins, InsideHealthPolicy) ...FDA's latest regulatory agenda again pushes back the date for an advanced notice of proposed rulemaking seeking comment on the recall process for products subject to the jurisdiction of FDA, stating it will be released December 2024... Sub. Req'd

US FDA's Cavazzoni To Manufacturers: Pay Attention To Data Received From CROs

(7/8, Anju Ghangurde, Pink Sheet) ...While addressing the recent Global Pharmaceutical Quality Summit in Mumbai, Patrizia Cavazzoni, director of the US FDA's Center for Drug Evaluation and Research, minced no words referring to a "very concerning trend" with data integrity problems pertaining to bioavailability (BA) and bioequivalence (BE) studies conducted by certain CROs in India... Sub. Req'd

Rockford Settles for Over $3M from Pharmacy Benefits Manager

(7/8, Forrest Nelson, WIFR) ...On Monday July 8, City Council approved a settlement with Express Scripts for $3.3 million..."This has always been about more than just recouping our expenses," Mayor Tom McNamara says. "Mallinckrodt and Express Scripts overcharged the City by over $400,000. Our objective was to hold these companies accountable, and our legal team, along with Haviland Hughes, did an outstanding job. However, the battle doesn't stop here. We need substantial structural reform to prevent other companies from hiking prices on lifesaving medications."... Full

Pharmacy Benefit Manager Reform Bill Inches Closer to Passage in Pa. Senate

(7/8, Ian Karbal, Pennsylvania Capital-Star) ...The state Senate Health and Human Services committee advanced a bill on Monday to increase oversight of pharmacy benefit managers...The Pennsylvania legislation would allow the state's Insurance Department to regulate certain aspects of pharmacy benefit managers' business that have been called anti-competitive... Full

Blue Cross Vermont, MVP Propose Substantial Premium Increases

(7/8, Timothy McQuiston, Vermont Biz) ...Vermonters are again facing steep premium growth for 2025 due to the cumulative impact of hospital costs, drug prices and state health care policy choices. Blue Cross and Blue Shield of Vermont projects that these trends will continue and require rate increases of 16.3% for individual health plans and 19.1% for small-group plans for Vermonters covered by Vermont Health Connect. MVP Health Care is proposing an average increase of 11.7% for individual plan coverage and a 9.3% increase for small-group coverage... Full

EU Regulators Call For More Registrations To Help Unlock Real-World Data Potential

(7/8, Neena Brizmohun, Pink Sheet) ...Regulators in the EU are encouraging data holders to register their data sources in the electronic catalog of real-world data sources that they launched in February and which as of June contained 216 registered data sources geographically distributed across various regions of the world... Sub. Req'd

Novo Nordisk Publicly Reprimanded Over Undisclosed Payments, Adding to Marketing Woes in UK

(7/8, Nick Paul Taylor, Fierce Pharma) ...The U.K.'s drug marketing watchdog has slammed Novo Nordisk for failing to disclose transfers of around 7.8 million British pounds ($10 million) to more than 150 bodies...The company responded by reviewing the payments it made in 2020, 2021 and 2022, revealing that its inconsistent "tagging" of U.K. vendors such as healthcare professionals and organizations had caused it to under-report its payments... Full

Canada Proposes New Obligations to Tackle Worsening Drug Shortages Problem

(7/8, Neena Brizmohun, Pink Sheet) ...A new requirement for drug companies on how much safety stock to maintain and a mechanism for extending the expiration date of a lot or batch of a drug if there is a shortage that could cause harm are among the measures Health Canada is proposing to adopt. Drug companies would have to maintain three months of safety stock in Canada for medicines that are critical and vulnerable to shortage if new proposals for addressing medicine shortages in the country are adopted... Sub. Req'd

Transforming India's Pharma Sector: Opportunities and Innovations Under Modi 3.0

(7/9, Anil Matai, Express Pharma) ...Anil Matai, Director General, OPPI shares an optimistic outlook for further enhancements in quality healthcare through continued reforms and policies aimed at fostering innovation and streamlining regulatory processes... Full

Taiwan's Tanvex Welcomes US Filgrastim Approval – After String Of CRLs

(7/8, Dean Rudge, Generics Bulletin) ...Tanvex Biopharma submitted an application for biosimilar filgrastim as far back as 2018. Now, after multiple setbacks, the firm has celebrated becoming a commercial-stage company in the US. Taiwan's Tanvex Biopharma has welcomed "moving beyond being a clinical/developmental stage company to a commercial company in the US," after receiving US Food and Drug Administration approval for its Nypozi (filgrastim-txid) biosimilar to Amgen's Neupogen... Global Sub. Full

Price Set for Russian Drug to Treat Alzheimer's and Dementia

(7/8, GxP News) ...The Federal Antimonopoly Service of Russia has agreed on prices for the domestic generic drug Rivastigmine-ET (rivastigmine). The department's press service has reported that the cost of the foreign reference drug Exelon has been reduced by an average of 11% compared to the registered prices... Full

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