Thursday, May 16, 2024

‘At The End Of The Day, It's A Huge, Huge Opportunity' – Teva's Rainey Talks Stelara

(5/15, David Wallace, Generics Bulletin) ...Tom Rainey, the firm's senior vice president of US market access, talks about the opportunities on the horizon and how the firm is balancing its partnership model with in-house development..."Teva is committed to biosimilars," Rainey emphasized. "We see this as [providing] huge cost savings to the healthcare system and customers, and that's what Teva has been about with our generics and our generic portfolio. That's something that we've focused on and it's part of our ‘pivot to growth' strategy," which the firm has been pursuing since it was introduced last year... Global Sub. Full

Teva Names New Executive Vice President of Teva Global Operations

(5/15, Contract Pharma) ...Teva Pharmaceutical Industries Ltd. has appointed Matthew Shields as Executive Vice President of Teva Global Operations, the company's manufacturing and supply division, effective June 3, 2024... Full

Teva Pharmaceuticals Names New EVP of Global Operations

(5/15, Kristen Kazarian, Powder & Bulk Solids) ...Shields succeeds Eric Drapé, who is leaving after 11 years with Teva Pharmaceuticals, including more than four years in the EVP role. Shields will be a member of Teva's Executive Leadership Team and be based at Teva's US headquarters in Parsippany, NJ. "I'm thrilled to welcome a transformational leader of Matthew's caliber to the executive team at Teva," said Richard Francis, Teva's president and CEO... Full

As a Result of AG Ferguson's Lawsuit, Teva Begins Delivery of More Than 54,000 Free Naloxone Kits to Washington

(5/15, Washington Attorney General Bob Ferguson) ...The kits will be available for free to Washingtonians as a result of a December 2022 resolution in Ferguson's lawsuit against Teva Pharmaceuticals for its role in fueling the opioid epidemic. As part of the $90.7 million resolution, Teva is sending the 54,120 kits to Washington in quarterly shipments over the next two years. Each kit contains two small nasal spray devices that rapidly reverse an opioid overdose. The first shipment of 6,765 kits arrived on Monday... Full

More Than 54,000 Free Opioid Overdose Reversal Kits Coming to Washington

(5/15, Grace Deng, Washington State Standard) ...Teva Pharmaceuticals is delivering the opioid overdose reversal kits in quarterly shipments over the next two years as part of a December 2022 resolution to a lawsuit by the state over the company's role in fueling the opioid epidemic. Washington has won $1.29 billion so far through lawsuits targeting corporations related to the opioid epidemic...Each naloxone kit, also known by the brand name Narcan, contains two dosages in nasal spray form that can be easily administered without medical training. This Monday, 6,765 of the 54,120 kits arrived... Full

Walgreens Launches Own Brand of Opioid Overdose Reversal Drug

(5/15, Mariam Sunny, Reuters) ...U.S. pharmacy chain operator Walgreens Boots Alliance said on Wednesday it has launched its own brand of popular overdose reversal drug, naloxone, which would be available over-the-counter...The U.S. FDA approved an OTC version of Emergent Biosolutions' Narcan last year, aimed at making it easier to access without a prescription. The health regulator had approved the first generic version of the medication in 2021, sold by Israeli drugmaker Teva Pharmaceuticals... Full

Boehringer Allies With Quallent For Push On Adalimumab

(5/15, David Wallace, Generics Bulletin) ...Boehringer Ingelheim has revealed that it will supply its 50mg/ml adalimumab biosimilar to Quallent Pharmaceuticals in the US, under a recently-announced initiative that also involves Teva and Alvotech's 100mg/ml Humira rival...With Teva holding the only approval for an interchangeable high-concentration adalimumab – Simlandi (adalimumab-ryvk), developed by partner Alvotech – there was only one possible supplier. Teva confirmed its involvement days later... Global Sub. Full

Organon Reports Boosted Growth In Biosimilars Portfolio Revenue

(5/15, Adam Zamecnik, Generics Bulletin) ...In what has been described by some analysts as a "solid start" to 2024, Organon has reported a 46% increase in revenue from its biosimilars portfolio amid broader improvement...The revenue of the company's biosimilars segment grew by 46% on an as-reported basis from $116m last year to $170m in the first quarter of 2024...Organon attributes this rise in revenue largely to incremental demand for its biosimilar Ontruzant (trastuzumab) stemming out of a Brazilian tender... Global Sub. Full

Roche Shares Jump On Obesity Drug Results from Early-Stage Trial

(5/16, Ludwig Burger, Reuters) ...Roche shares gained as much as 4.7% on Thursday after an early-stage trial showed that a newly-acquired obesity drug candidate led to significant weight loss, a key step in Swiss drugmaker's race to join the booming obesity treatment market. Roche said the study in the first of three trial stages required for regulatory approval showed the compound known as CT-388 yielded weight loss of 18.8%, when adjusted for a placebo effect, after 24 weeks in otherwise healthy adults with obesity... Full

India's Mankind Pharma's Q4 Profit Jumps On Strength in Chronic Drugs Segment

(5/15, Ashna Teresa, Reuters) ...Indian pharmaceutical company Mankind Pharma posted a more than 65% rise in its fourth-quarter profit on Wednesday, helped by strong domestic demand in its chronic drugs segment..."We have further strengthened our chronic product portfolio with strategic in-house launches, coupled with in-licensing of products like Symbicort — a globally renowned inhaler from AstraZeneca," Managing Director Rajeev Juneja said in a statement... Full

Eisai Predicts Sharp Leqembi Sales Increase As Launch Efforts Begin to Bear Fruit

(5/15, Fraiser Kansteiner, Fierce Pharma) ...Eisai laid out an ambitious goal to hit 56.5 billion yen (roughly $364 million) in global Leqembi sales for the 2024 fiscal year, which will wrap up next March...Though Leqembi's launch sputtered out of the gate thanks to factors ranging from reimbursement delays to diagnostic and treatment logistics, the drug has been picking up the pace in recent months. The med's sales more than doubled between the third and fourth quarters of the Japanese fiscal calendar... Full

BeiGene Looks at New Partnerships, With a Full Cancer Pipeline and Growing Footprint

(5/15, Drew Armstrong, Endpoints News) ...In an interview with Endpoints News, BeiGene CEO John Oyler talked through the company's expansive oncology portfolio and how its strategy would play out in the coming years. In September, Novartis ended a second collaboration program with BeiGene, handing back the rights to its anti-PD-1 antibody tislelizumab. But BeiGene says it has more than 35 drugs in development, and plans to look for places where it can strike new deals... Full

US FDA Approves Expanded Use of Bristol Myers' Cancer Cell Therapy

(5/16, Sneha S K and Bhanvi Satija, Reuters) ...The U.S. health regulator on Wednesday approved the expanded use of Bristol Myers Squibb's cancer cell therapy Breyanzi for the treatment of adults with a type of blood cancer called follicular lymphoma, that has returned or has not responded to prior treatments...Bristol expects that additional approval could roughly double the addressable market for Breyanzi. The company is working to expand its manufacturing capacity for its CAR-T therapies - Abecma and Breyanzi - due to increasing demand... Full

Pfizer Offers Up to $250Mn to Settle Thousands of Zantac Cancer Lawsuits

(5/15, Oliver Barnes and Ian Johnston, Financial Times) ...Pfizer has agreed to pay up to $250mn to settle more than 10,000 US lawsuits over cancer risks associated with its now-discontinued heartburn drug Zantac, according to people familiar with the deal...Boehringer Ingelheim and GSK are also defending thousands of cases in state courts. Both drugmakers declined to comment... Sub. Req'd

GoodRx Gets Back in Kroger's Good Graces, Will Work Directly with Grocer

(5/15, Lydia Ramsey Pflanzer, Endpoints News) ...GoodRx said on Wednesday that it has won back its relationship with Kroger to offer prescription discount coupons to people at its pharmacies, but this time it will work directly with the grocer to do it...Through direct contracts with retail pharmacies, GoodRx works with a pharmacy to set the prices they're able to provide to consumers who aren't paying with insurance. In Kroger's case, that'll look like nearly 50% savings off generic medications via a GoodRx coupon starting June 1, GoodRx said on Wednesday... Full

Panelists Call for Consistent Education, Support to Improve Patient Comfort With Biosimilars

(5/15, Skylar Jeremias, The Center For Biosimilars) ...Panelists during a discussion at the Festival of Biologics USA emphasized the importance of patient-centered communication and education strategies to encourage patient comfort with biosimilars across disease states, highlighting lessons learned from patient focus groups...Anna Hyde, vice president of advocacy and access at the Arthritis Foundation, and Melody Chang, vice president of pharmacy operations at the American Oncology Network, began the discussion talking about improving patient education and communication strategies regarding biosimilars... Full

First Drop in Overdose Deaths in 6 Years, US Preliminary Data Shows

(5/15, Pratik Jain, Reuters) ...The number of deaths from drug overdose fell 3% to 107,543 in 2023 from the previous year, according to preliminary data from the U.S. Centers for Disease Control and Prevention released on Wednesday..."The data show we still lost over 100,000 people last year; meaning, there are still families and friends losing their loved ones to drug overdoses at staggering numbers," CDC Chief Medical Officer Dr. Deb Houry said in a statement. "This progress over the last 12 months should make us want to reinvigorate our efforts knowing that our strategies are making a difference," Houry said... Full

Novo's Wegovy Will Bankrupt Health System, Senator Sanders Says

(5/15, Madison Muller and Naomi Kresge, Bloomberg) ...Senator Bernie Sanders is upping the pressure on Danish drugmaker Novo Nordisk A/S to lower the cost of its blockbuster weight-loss drug Wegovy, warning in a new report that if prices don't come down, the medication risks bankrupting the US health-care system... Sub. Req'd

Wegovy Could Bankrupt US Health System, Sanders Says in New Report

(5/15, Nathaniel Weixel, The Hill) ...Unless prices dramatically decline, Wegovy and weight loss drugs could push Americans to spend $1 trillion per year on prescription drugs, the report concluded. "Pricing drugs based on their value cannot serve as a blank check, or the sole determinant for how we understand what to pay for essential goods," the report stated. As important as these drugs are, they will not do any good for the millions of patients who cannot afford them."...In a statement, a Novo Nordisk spokesperson said the company is reviewing the report and continues to cooperate with the investigation... Full

Senate Judiciary Plans Hearing On Drug Prices, Still Awaits Patent Reform Floor Votes

(5/15, Gabrielle Wanneh, InsideHealthPolicy) ...The Senate Judiciary Committee will hold a hearing next week on ways to reduce drug prices and increase pharmaceutical competition as it continues to await Senate floor action on a package of bills it unanimously advanced over a year ago to reform drug patent policies. The hearing may also touch on the role of pharmaceutical research conducted by the National Institutes of Health, coming as key Democrats push the administration to use its new draft framework on march-in rights to seize patents when prices for drugs developed using NIH funding are unreasonably high... Sub. Req'd

HHS Drops ‘Stacking' Provision in Medicaid Drug Rebate Proposal

(5/15, Ganny Belloni, Bloomberg Law) ...In an update released Wednesday, the Centers for Medicare & Medicaid Services said it won't finalize a provision in the proposed rule (RIN 0938-AU28) that would have required companies to "stack" discounts and rebates throughout a transaction when reporting best prices for the Medicaid drug rebate program. Instead, the agency said it will collect more information from manufacturers on their price calculation methodologies before pursuing changes through future rulemaking... Sub. Req'd

CBER's Tierney: IRA Could Impact Rare Disease, Small Molecule Development

(5/15, Jessica Karins, InsideHealthPolicy) ...A top official at FDA's Center for Biologics Evaluation and Research says the lack of an exemption under the Inflation Reduction Act drug negotiation program for drugs approved for multiple rare diseases is shifting drug developers' focus and could result in less investment in the rare disease space, in an unusual FDA comment on one of the Biden administration's chief legislative achievements and a favorite target of Republicans and the pharmaceutical industry... Sub. Req'd

Chinese Biotech Crackdown Would Reset U.S. Drug Development

(5/15, Maya Goldman, Axios) ...Lawmakers in the House of Representatives on Wednesday are expected to set in motion a massive reordering of how U.S. pharmaceuticals are developed and made, by advancing a contracting ban on five key Chinese research firms...The Senate version of the bill didn't forecast a major effect on drug access or pricing. But the House version could be deemed to hurt drug development and possibly add significant costs to federal programs, said Max Reale, analyst for Compass Point. That could derail the bill or force major revisions, he wrote in a note this week... Full

House Oversight Bill Gives Companies Longer Time To Cut Ties With Foreign Biotech

(5/15, Jessica Karins, InsideHealthPolicy) ...Members of the House Committee on Oversight & Accountability voted 32-2 Wednesday (May 15) to advance a bill that would bar American companies from working with some foreign-owned biotechnology companies after a period of eight years, as well as banning federal contracting with those companies -- a longer timeframe than allowed by another House committee's version of the bill... Sub. Req'd

As Biosecure Bill Mores Forward, Clock Ticking For Industry To Move Away From Chinese CDMOs

(5/15, M. Nielsen Hobbs, Pink Sheet) ...The new version of the BIOSECURE Act moving through the House gives industry more time than the original draft to transition away from Chinese biotech suppliers, but it may not give all of them enough...The bill that passed committee on May 15, sets a horizon almost as long as the one that a Biotechnology Innovation Organization survey found that firms might need to transfer the production of an approved product, but not quite. BIO reported that firms could need up to eight years, and the legislation gives them, as of this date, 7.64 years and dropping... Sub. Req'd

Euro Convergence: Experts Discuss Supply Chain Challenges, Potential Solutions

(5/15, Ferdous Al-Faruque, Regulatory Focus) ...As regulators grapple with supply chain issues and preventing drug shortages, one expert says he foresees European regulators requiring manufacturers to include supply chain information in their marketing applications that could delay approvals... Full

Industry Calls For More Clarity On EU Compulsory Licensing Proposal

(5/15, Francesca Bruce, Pink Sheet) ...Industry groups say the initiative will undermine innovation and the competitiveness of European companies, impeding Europe's ability to tackle future crises effectively. "Key unresolved issues" relating to the European Commission's proposals on EU-level compulsory licensing must be addressed, such as whether companies may be forced to share trade secrets, say several industry groups, including EFPIA and MedTech Europe, which represent the European R&D-based pharmaceutical and medical devices industries respectively... Sub. Req'd

UK Subscription Contracts Will Target Antimicrobials Against ‘Critical' Pathogens

(5/15, Ian Schofield, Pink Sheet) ...Pharma companies seeking a subscription-style contract for new antimicrobials will need to meet a number of requirements, such as guaranteeing surety of supply, meeting key performance measures and complying with specified manufacturing standards...Two new expert panels will be responsible for determining eligibility and awarding contracts. In a consultation last year, 95.5% of respondents agreed with the overall purpose of the subscription model, according to NHS England... Sub. Req'd

Global Fight Intensifies Against Superbug ‘Menace'

(5/15, Clive Cookson, Financial Times) ...A surge in funding is set to boost the global battle against drug-resistant superbugs, with the UK government and pharmaceutical company GSK committing a total of £130mn to tackle growing antimicrobial resistance...The funding — £85mn from the UK government and £45mn from GSK — is not aimed at developing new antibiotics, which is covered by other programmes. It is intended primarily to improve access to existing drugs and make sure they are used more effectively, especially in poorer countries, so that microbes are less likely to evolve resistance... Sub. Req'd

GSK, UK Government Budget £130M to Fight Global Antimicrobial Resistance

(5/16, Anna Brown, Endpoints News) ...GSK said it is the first founding partner of the Fleming Initiative with its investment of £45 million ($57 million). The initiative will use technology and artificial intelligence to discover how drug-resistant infections are passed and to find new ways to survey AMR transmissions..."The Fleming Initiative will bring together global resources and expertise from across different sectors to better understand the factors contributing to this growing threat and most importantly, drive action and solutions," GSK CEO Emma Walmsley said in a statement... Full

French Health Groups Put Forward Proposals to Limit the Damage of Worsening Drug Shortages

(5/16, Lauren Chadwick, Euronews) ...Pharmaceutical companies' lack of transparency leads to rising drug prices and less control over public resources, the group of health organisations say...In a joint report, 14 civil society organisations outlined their recommendations to solve a "situation that has only worsened" since 2018. The French medicines regulator signalled 4,925 drug shortages in 2023, compared to 3,761 in 2022 and 2,160 in 2021. A 2024 survey from France Assos Santé, which represents patients, found that 44 per cent of people in France said they had faced a drug shortage this year... Full

Heart Disease, Diabetes Drugs to Cost Less as Govt Cuts Essential Medicine Prices

(5/16, Somrita Ghosh, Mint) ...The government has cut prices of 41 commonly used medicines and six formulations related to cardiovascular diseases, diabetes, and other conditions. Prices have been slashed for drugs meant for diabetes, body pain, cardiovascular conditions, liver issues, antacids, infections, allergies, multivitamins, and antibiotics, as per a notification from the Department of Pharmaceutical and National Pharmaceutical Pricing Authority... Full

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.