Tuesday, June 18, 2024

Teva in Talks to Settle US Lawsuit Alleging MS Drug Kickbacks

(6/17, Nate Raymond, Reuters) ...Teva Pharmaceutical Industries Ltd said it is in active talks to settle a U.S. Department of Justice lawsuit alleging it used charities that help cover Medicare patients' out-of-pocket drug costs as a means to pay kickbacks to boost sales of its multiple sclerosis drug Copaxone..."The parties are actively engaged in settlement negotiations and Teva is optimistic that the parties can reach a resolution, but additional time is needed to do so," Teva's lawyers wrote... Full

US Court Sides With Amneal On ProAir Patents As Teva Vows Appeal

(6/17, Urte Fultinaviciute, Generics Bulletin) ...The inhaler patent saga goes on. A US District Court orders Teva to either de-list or correct patents for its inhaler ProAir HFA, but the originator disagrees and gets ready to appeal. "Teva stands behind the company's intellectual property and we will appeal this ruling," a Teva spokesperson has told Generics Bulletin in response to a recent US court decision in the legal dispute between the firm and Amneal over inhaler patent listings... Global Sub. Full

Drug Shortages Keep On Growing. Older, Injectable Medicines Are Among The Most Vulnerable

(6/17, Tom Murphy, Associated Press) ...There were 48 new shortages recorded this year through March, according to the data, published by the American Society of Health-System Pharmacists. Still, [Erin] Fox also sees positive news developing. The associate chief pharmacy officer at University of Utah Health spoke recently with The Associated Press. The conversation has been edited for clarity and length... Full

Countries Face Growing Drugs Shortage with Older Medicines Among Most Vulnerable

(6/18, Euronews) ...A statement last week from the Pharmaceutical Group of the European Union, meanwhile, highlighted doctors' and pharmacists' concerns about a rise in drug shortages in Europe...Erin Fox, the associate chief pharmacy officer at the University of Utah Health, said US regulators halted inspections, for instance, during the pandemic and are now finding issues to fix at some factories...Experts told Euronews Health last year that pharmaceutical companies make less money from generic drugs and do not keep stocks of these medicines as well. Fox says that sometimes a treatment is delayed or a patient may have to take a capsule instead of a pill... Full

Collaborative Solutions Are Needed to Address and Mitigate America's Drug Shortages

(6/17, Tommy Pourmahram, AJMC) ...Our view is that most drug shortages fall within 3 key categories: marketwide supply constraints, product-specific issues, and reimbursement and market access limitations. Some causes within these categories include sourcing or manufacturing limitations, natural disasters, market economics, changes in prescribing or patient demand patterns, and product discontinuation... Full

Alvotech Partners With Advanz On European Eylea Biosimilar

(6/18, David Wallace, Generics Bulletin) ...Alvotech has announced its latest European biosimilars partnership, collaborating with Advanz on both 2mg and 8mg aflibercept rivals to Eylea. The deal follows several other recent alliances as well as a raise in Alvotech's full-year revenues guidance to as much as $500m... Global Sub. Full

Cranbury Forms From Tris Pharma, With First Generic DMD Treatment Deflazacort

(6/17, Dean Rudge, Generics Bulletin) ...Tris Pharma has handed over the keys to its generics portfolio and pipeline to a new subsidiary, Cranbury Pharmaceuticals, which has debuted competition to PTC Therapeutics' Emflaza (deflazacort) oral suspension...Operating out of Tris' headquarters in Monmouth Junction, New Jersey, Cranbury will market more than 20 generic medicines and look to advance a "diverse pipeline with the potential to address a range of disorders and diseases."... Global Sub. Full

AstraZeneca Backs Up Calquence's Potential in Mantle Cell Lymphoma with Detailed Data

(6/17, Kevin Dunleavy, Fierce Pharma) ...Six weeks after revealing that an interim analysis of a phase 3 trial showed that AstraZeneca's blood cancer drug Calquence plus chemoimmunotherapy worked in previously untreated mantle cell lymphoma patients, the company has put numbers to its claim. In the ECHO study, adding Calquence to the combination of bendamustine and rituximab (BR) reduced the risk of disease progression or death by 27%... Full

Amgen Nabs New Blincyto Approval for Certain Type of Leukemia

(6/17, Lia DeGroot, Endpoints News) ...The FDA on Friday gave its stamp of approval to Amgen's Blincyto to treat both adults and children with the most common type of acute lymphoblastic leukemia, marking the third indication for the drug. The approval is based on positive results from the NIH-funded Phase 3 E1910 clinical trial, which evaluated overall survival in patients 1 month and older with the blood cancer known as CD19-positive Philadelphia chromosome-negative B cell precursor acute lymphoblastic leukemia, or B-ALL, in the consolidation phase of multi-phase chemo... Full

India's Lupin Announces CEO Pick for New Subsidiary as it Moves into the CDMO Arena

(6/17, Fraiser Kansteiner, Fierce Pharma) ...Lupin on Monday unveiled its new subsidiary, Lupin Manufacturing Solutions, which is poised to work on the development, production and sale of active pharmaceutical ingredients...At the same time, Lupin announced Abdelaziz Toumi will take the reins as CEO of the newly formed unit. Toumi's track record includes stints at Bayer, Merck, Catalent, Lonza and KBI Biopharma. He will be based in Switzerland and spend a considerable amount of time in India, Lupin said... Full

Drugmaker Apotex Accuses Amarin of Vascepa Monopoly in US Lawsuit

(6/17, Mike Scarcella, Reuters) ...Drugmaker Apotex has sued its rival Amarin in federal court in New Jersey, accusing it of thwarting competition for a generic version of its heart drug Vascepa and causing wholesalers and other buyers to pay artificially higher prices. The lawsuit, filed on Friday, said Amarin "has engaged in a calculated anticompetitive scheme" for more than a decade to protect Vascepa from drugmakers that want to market a lower-cost generic... Full

Cardinal Health VP of Emerging Therapies Talks Regulation and Adoption Challenges for Biosimilars

(6/17, Nicholas Saraceno, Pharmaceutical Commerce) ...In an interview with Pharma Commerce Editor Nicholas Saraceno, Fran Gregory, PharmD, Vice President of Emerging Therapies, Cardinal Health discusses the growing biosimilars market and the challenges associated with regulation and adoption... Full

Amazon Pharmacy Expands RxPass Subscription Service to Medicare Patients

(6/18, Heather Landi, Fierce Healthcare) ...A Medicare beneficiary who takes at least one medication available through RxPass could save approximately $70 per year and a beneficiary who takes two or more medications could save even more, John Love, vice president of Amazon Pharmacy, said in an interview. The online retail giant estimates that if all Medicare beneficiaries, a population of about 50 million people, transitioned their eligible medications to RxPass, Medicare spending would be reduced by nearly $2 billion, and customer out-of-pocket spending would also decrease... Full

More Than 6 Months After Allowing Narcan Sales Over-the-Counter, Advocates Say its Price Keeps it Inaccessible

(6/17, María Marta Guzmán, WBIR) ...Around six months ago, the U.S. Food and Drug Administration started allowing Narcan to be sold over-the-shelf in grocery stores and drug stores. It was thought that by removing restrictions around the overdose-reversing medicine, it would be accessible to more people and could be used to save more lives. However, advocates said Monday that its relatively high price point has kept it inaccessible for many people. Prices range start at around $45 in many East Tennessee stories... Full

Generic Drug Group's Suit Over Pricing Law Dismissed by Judge

(6/17, Celine Castronuovo, Bloomberg Law) ...Judge Virginia M. Kendall of the US District Court for the Northern District of Illinois said in a status hearing that she was granting Illinois Attorney General Kwame Raoul's (D) motion to dismiss a lawsuit from the Association for Accessible Medicines. AAM had argued the law (Public Act 103-0367) prohibiting certain price hikes on generic drugs was unconstitutional. Kendall also rejected AAM's motion for a preliminary injunction on the law, which the group had argued was necessary to avoid "significant economic losses they will not be able to recoup."... Sub. Req'd

How to Deliver Lower Prices for Seniors A Market-Based Reform for Expensive Drugs with Limited Competition

(6/18, Theo Merkel, Manhattan Institute) ...A new approach is particularly important for drugs with little or no therapeutic competition that are covered under Medicare Part B—which are some of the most expensive on the market today and whose prices would not be affected by IRA price controls or by MFN. This issue brief proposes a market-based reform that would lower prices on these drugs. It would incentivize, but not require, Medicare Advantage plans to negotiate prices with drug manufacturers for novel therapeutics. If a sufficient number of MA plans reach a contract with the manufacturer, the drug would be covered for all Medicare beneficiaries. The price that results from these negotiations would then be used to set reimbursement rates for the drug, both for MA plans and for providers in traditional fee-for-service Medicare... Full

PDUFA VIII: Continuous Fee Increases May Be Wearing On Sponsors

(6/17, Derrick Gingery, Pink Sheet) ...Industry may no longer be willing to accept user fee increases and more hiring as the key to US Food and Drug Administration improvements, a potential change of strategy for handling the prescription drug user fee program...Andrew Emmett, FDA liaison and executive director of US regulatory policy and global intelligence at Pfizer Inc., said June 17, during a session at the DIA Global Annual Meeting that PDUFA has reached a point where the old formula "is having diminishing returns." "We can't just throw people and staff and metrics at the problem and expect to see the same sort of results," Emmett, a former PDUFA negotiator for industry, said... Sub. Req'd

Flat-Lining US FDA: Failure To Invest May Have Consequences

(6/17, Michael McCaughan, Pink Sheet) ...The FDA is facing a budget cut at a time when most of its activities are going well. But the agency soon may need additional spending to continue functioning well...The agency relies heavily on user fees, and those industry payments increase each year per agreements negotiated on five-year cycles with the regulated sectors. So, the FDA's overall budget will increase under the House bill to $6.75bn... Sub. Req'd

FDA Finalizes Guidance Giving ANDA Facilities Time to Comply with cGMP

(6/17, Ferdous Al-Faruque, Regulatory Focus) ...The US Food and Drug Administration will give generic drug manufacturers more time to bring facilities not fully compliant with its current good manufacturing practice (cGMP) requirements up to speed. The agency's objective is to reduce first assessment cycle facility-related delays, ultimately leading to delayed approvals for premarket applications, and incentivize sponsors not fully ready to submit their applications... Full

Medicines For Europe Highlights Sector Challenges As It Celebrates Milestone Anniversary

(6/17, David Wallace, Generics Bulletin) ...At the association's landmark 30th annual conference – preceded earlier in the week by its 18th legal affairs conference – Medicines for Europe highlighted the significance of the current review of European pharmaceutical legislation for the industry, calling for "EU-wide solutions to tackle medicines shortages, clearer laws to allow patients to access generic and biosimilar medicines after patent expiry, and strong incentives for affordable value added medicines innovation and repurposing."... Global Sub. Full

EMA & Health Canada Harmonize Anonymization Reporting For Clinical Trial Reports

(6/17, Vibha Sharma, Pink Sheet) ...Companies submitting clinical data for publication under the European Medicines Agency's Clinical Data Publication policy and Health Canada's Public Release of Clinical Information initiative can now provide a single anonymization report to both regulators. This report would explain the steps taken by sponsors to ensure the anonymized data poses a low risk of re-identification... Sub. Req'd

Canadian Pharmacy Announces Free Shipping on Generic Drugs Including Modafinil and Insulin Making RX Meds More Accessible for U.S. Customers

(6/18, SaveRxCanada.to) ...SaveRxCanada.to is pleased to announce that they are now offering free shipping on all generic medication orders. This exciting new offer is designed to make it even easier for U.S. customers to access affordable healthcare solutions through a Canadian pharmacy...By offering free shipping on generic orders including Insulin and Modafinil, SaveRxCanada.to is helping to make essential medications even more accessible to those in need. Modafinil is a medication that promotes wakefulness and is used to treat conditions like narcolepsy, sleep apnea, and shift work sleep disorder... Full

Big Pharma Influence Hangs Over Europe's Medicines Regulator

(6/17, Leïla Miñano, Maria Maggiore, Manuel Rico and Catrien Spijkerman, EUobserver) ...Investigate Europe has found that the regulator is beset by several conflicts of interest with concerns over professional and financial ties to industry. It is also facing growing criticism for fast-tracking drugs that could pose serious risks to patients...In 2022, industry fees accounted for almost 86 percent of the regulator's €417m in revenues its latest accounts show. Investigate Europe can reveal how just 21 companies provided half of these fees received for drug authorisations. Novartis gave almost €20m, followed by Pfizer, AstraZeneca, Jannsen, Roche and GlaxoSmithKline, all of them paying more than €10m, data from freedom of information requests reveals... Full

NPPA Fixes Retail Prices for 54 Drug Formulations and 8 Special Products

(6/17, Sanket Koul, Business Standard) ...The National Pharmaceutical Pricing Authority (NPPA) has announced the fixing of retail prices of 54 drug formulations and eight special feature products. The decision to revise the prices of the formulations was taken during the authority's 124th meeting. Prices have been fixed for drugs and formulations meant for diabetes, hypertension, heart issues, multivitamins, bacterial infections, and allergies, according to a notification from the Department of Pharmaceuticals and the NPPA... Full

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