Friday, July 26, 2024

Teva Baltic to Expand Plant Area, Hire More Staff – Media

(7/25, Justina Vaišvilaite-Braziuliene, Lithuanian News Agency - ELTA) ...Teva Pharmaceutical Industries, one of the world's largest manufacturers of generic medicines, is investing in Vilnius-based Teva Baltic to build two additional storeys and employ up to 27 people, Verslo žinios reports...The investment is intended to boost the production of medicines for infectious diseases... Sub. Req'd

Teva's Q2 Outlook: Key Developments In Biosimilars And Pipeline Drugs

(7/26, Stephen Ayers, Seeking Alpha) ...Teva Pharmaceutical's stock is up 69% since December, driven by legal resolution, blockbuster drugs, debt reduction, and new product launches. Recent developments include the launch of biosimilars and generics, positive data on Uzedy and Ajovy, and an accelerated timeline for TEV-48574. Financially, Teva's current ratio is under 1, with upcoming debt maturities posing a challenge. Recommendation remains "Hold" pending Q2 earnings... Full

America Is Running Out of Generic Drugmakers. Another One Is On the Brink.

(7/26, Liz Essley Whyte, The Wall Street Journal) ...To break even, USAntibiotics must double its commercial sales -- or line up the U.S. government as a customer...In 2022, company representatives spoke with U.S. Secretary of Health and Human Services Xavier Becerra and [FDA] Commissioner Robert Califf about opportunities to work with the government. The company hasn't heard back, a spokesman said. White House officials told USAntibiotics that there isn't funding under the Defense Production Act, the spokesman said. An HHS spokeswoman pointed to a request for information about drug shortages and said USAntibiotics hadn't responded to it. She also said Congress had given the agency little money for its program aimed at ensuring critical medicines are made in the U.S. The White House didn't reply to requests for comment... Sub. Req'd

Sanofi's Immunology Bet Starts to Pay Off

(7/25, Jacob Bell, BioPharma Dive) ...There, the company has more than half a dozen experimental medicines in mid- to late-stage testing. The list includes a drug named amlitelimab, which Sanofi acquired through the billion-dollar acquisition of a U.K.-based biotechnology company in 2021...On Thursday, Sanofi and Teva said they have sped up the development of duvakitug and now expect high-level results from a mid-stage program toward the end of this year. The program is testing the drug in patients with ulcerative colitis or Crohn's disease... Full

Sanofi Eyes RSV Antibody for its Next Blockbuster While Dupixent Brings in Record Sales

(7/25, Anna Brown, Endpoints News) ...During a media call, CFO François-Xavier Roger said Sanofi expects to rake in over €1 billion in sales for Beyfortus this year, despite supply falling short earlier this year due to demand exceeding manufacturing capacity. The asset, co-developed with AstraZeneca, generated €547 million in sales for Sanofi in 2023... Full

AbbVie Beats Expectations with Smaller Humira Slide — and Big Gains for Next Autoimmune Blockbusters

(7/25, Kyle LaHucik, Endpoints News) ...On Thursday, AbbVie shared second-quarter financial results that show its cornerstone immunology medication eroded more slowly than expected. Combined with revenue growth from its next two autoimmune blockbusters, Skyrizi and Rinvoq, the Chicago-area company said sales rose 4.3% year-over-year to $14.4 billion... Full

AbbVie Lifts 2024 Profit Forecast, Shares Hit Record High

(7/25, Leroy Leo and Patrick Wingrove, Reuters) ...Humira's global sales fell nearly 30% to $2.81 billion in the second quarter, but still topped analysts' estimate of $2.76 billion, according to LSEG data. The loss of exclusivity has forced AbbVie to reduce the drug's net price to maintain market share with industry middlemen known as pharmacy benefit managers that determine much patient access to prescription drugs... Full

Indian Drugmaker Cipla Beats Q1 Profit View On Strong Demand; Shares Hit Record High

(7/26, Rishika Sadam and Kashish Tandon, Reuters) ...The company reported an 18.3% rise in consolidated net profit to 11.78 billion rupees ($140.8 million) for the quarter ended June 30, beating analysts' estimate of 11.10 billion rupees, as per LSEG data...Sales in North America grew 13% during the quarter, primarily driven by Cipla's respiratory drug Albuterol and Lanreotide, the generic version of Bristol-Myers Squibb's blockbuster cancer treatment drug Revlimid...Its overall revenue rose 7%, but fell short of analysts' expectations of a nearly 8% increase, mainly due to weakness in Cipla's trade generics business in India... Full

Indivior Shares Soar On $100 Mln Buyback, Opioid Addiction Drug Sales Rise

(7/25, Shanima A, Radhika Anilkumar, Reuters) ...Specialty pharmaceutical company Indivior launched a $100 million share buyback on Thursday after logging a higher profit in the second quarter, helped by strong demand for its opioid addiction treatment, boosting its shares as much as 22%. The London-listed company, which recently shifted its primary listing to the United States, said revenue for the opioid addiction treatment Sublocade rose 24% in the second quarter to $192 million... Full

Taking Advantage of Recent Successes, Roche Will Push Obesity Drugs Faster, Flirts with M&A

(7/25, Max Gelman and Anna Brown, Endpoints News) ...The bid to accelerate the Carmot drugs' development is buoyed by Roche's confidence that they can be superior to other weight loss drugs already on the market, such as Novo Nordisk's semaglutide (Ozempic, Wegovy) and Eli Lilly's tirzepatide (Mounjaro, Zepbound). And perhaps looking to capitalize on the positive momentum, Roche CEO Thomas Schinecker also said his company could still be looking at other M&A moves in obesity... Full

AstraZeneca CEO Talks Dual Supply Chain Strategy

(7/26, Madison Mills, Yahoo! Finance) ...AstraZeneca reported a second-quarter earnings beat, raising its full-year guidance. However, with the upcoming US election potentially impacting operations in regions like China, AstraZeneca CEO Pascal Soriot joins Yahoo Finance reporter Anjalee Khemlani on Catalysts to discuss the company's strategy for navigating these challenges. Soriot outlines AstraZeneca's approach to global expansion, particularly regarding supply chains... Full

Fresenius Kabi and Formycon Receive Positive CHMP Opinion for FYB202, An Ustekinumab Biosimilar Candidate

(7/26, Fresenius Kabi) ...Committee for Medicinal Products for Human Use of the European Medicines Agency recommends approval of FYB202 for the treatment of severe inflammatory diseases in the fields of gastroenterology, dermatology, and rheumatology. FYB202 is part of Fresenius Kabi's expanding biosimilars portfolio focused on autoimmune diseases and oncology. Approval decision by the European Commission is expected until early Q4 2024... Full

Sun Pharma Receives US FDA Approval for Drug to Treat Alopecia Areata

(7/26, Anjali Singh, Business Standard) ...Sun Pharmaceutical Industries has received US Food and Drug Administration approval for LEQSELVI (deuruxolitinib) that is used for treating an autoimmune disorder in adults..."LEQSELVI represents a significant advancement for patients with severe alopecia areata," said Abhay Gandhi, chief executive officer of North America business at Sun Pharma. "Our growing dermatology portfolio is excited to include this innovative treatment."... Full

Generic Drugmaker Viatris to Cut Over 200 Jobs with Cork Plant Closure

(7/25, Dominic Coyle and Emmet Malone, The Irish Times) ...The US company said it plans to close its active pharmaceutical ingredient manufacturing operation at Little Island, subject to consultations with union and other employee representatives. "The announcement comes after a thorough assessment of the site, which unfortunately concluded it was no longer viable due to challenging market and site dynamics," the company said. "In particular, declining demand has resulted in underutilisation of our production capacities at this particular site."... Full

FDA Finds Data Integrity, Sterility Problems at Indian Drugmaker

(7/25, Joanne S. Eglovitch, Regulatory Focus) ...The US Food and Drug Administration has warned Brassica Pharma for numerous good manufacturing practice violations, including multiple instances of employees falsifying sterility and environmental monitoring data and lax controls to prevent microbiological contamination... Full

LTC Pharmacies Launch Call For IRA Tweaks To Avoid Financial Strain

(7/25, Gabrielle Wanneh, InsideHealthPolicy) ...Members of the Senior Care Pharmacy Coalition met with lawmakers Wednesday (July 24) to urge them to adjust the current payment model for long-term care pharmacies, saying if left unchanged the new maximum fair prices Medicare negotiates for 10 of its costliest Part D drugs may threaten the operations of these pharmacies and lead many to close permanently in 2026... Sub. Req'd

Updated: AstraZeneca Says There's ‘Very Limited' Impact On Farxiga After US Drug Pricing Negotiations

(7/25, Reynald Castañeda and Nicole DeFeudis, Endpoints News) ...Ruud Dobber, AstraZeneca's biopharma business unit head, reiterated that the price impact on Farxiga "will be very limited" considering that the new price would come into effect in January 2026 and its loss of exclusivity for the drug is only a few months later in April. It's unclear whether AstraZeneca has accepted the federal government's final offer...When asked how the IRA will impact AstraZeneca's development decisions, Soriot said on a Thursday investor call that "we are shifting a little bit away from small molecules."... Full

Darzalex, Medicare Negotiation And The Strategic Importance Of Combination Products

(7/25, Cathy Kelly, Pink Sheet) ...Johnson & Johnson is "confident" its blockbuster, next-generation Darzalex Faspro for multiple myeloma is a separate product from its predecessor, which would excuse it from Medicare price negotiation at the same time, according to J&J Innovative Medicine worldwide chair Jennifer Taubert..."We do have very good confidence that Darzalex Faspro is treated separately than Darzalex IV," Taubert said. "And so, yes, we continue forward with that perspective on that."... Sub. Req'd

Report: CVS to Pay $45M As Part of Settlement with Illinois

(7/25, Paige Minemyer, Fierce Healthcare) ...CVS Health's Caremark has agreed to pay $45 million to Illinois to settle allegations that it failed to pass through rebates in a recent contract, according to a new report...In the settlement, however, the PBM denies wrongdoing. The company noted in a statement to Stat that Illinois recently renewed its contract with Caremark. "We look forward to continue working with the state for the benefit of its employees," the company told the news outlet... Full

State Health Care Committee Continues to Press Pharmaceutical Middlemen

(7/25, Dilpreet Raju, Capitol News Illinois) ...State legislators resumed a series of hearings this week to scrutinize pharmacy benefit managers – a highly concentrated industry that critics say drives up the cost and limits availability of prescription drugs...Connor Rose, a lobbyist for the Pharmaceutical Care Management Association, a trade association representing various PBMs, pushed back against the idea that top PBMs possess too much power over the industry. "This is a competitive environment, there is a lid for every pot," Rose told the committee. "If one PBM is not going to do something for an employer or a union or the state of Illinois, there's another PBM that will fill its place."... Full

State Reps Unanimously Back Rx Drug Cost Caps. Pharmacy Middlemen Regulation

(7/25, Chris Lisinski, Telegram & Gazette) ...Reining in prescription drug prices and subjecting industry middlemen to greater scrutiny are the next major health care reforms en route to private negotiations after the House unanimously approved legislation Wednesday. Representatives voted 158-0 on a pharmaceutical cost control and oversight bill (H 4891), another mile marker along the way to sweeping reforms as the Legislature settles into its final week for major business... Full

EU First-Half New Drug Approvals Rebound After Slump In 2023

(7/25, Ian Schofield, Pink Sheet) ...The number of medicines containing a new active substance approved for pan-EU marketing in the first six months of 2024 rose to near-normal levels after an unusually sharp dip in the 2023 period. The approvals were again led by cancer drugs, with therapies for blood disorders a close second, while half of the approvals were treatments for rare diseases... Sub. Req'd

Flexible Approach To Multilingual Packaging Now Standard In EU

(7/25, Vibha Sharma, Pink Sheet) ...A new coordinated approach for preparing and evaluating multilingual packaging for drugs assessed under the EU's mutual-recognition and decentralized (MR/DC) procedures has now been established as standard practice by regulators, after it proved successful in a four-year pilot... Sub. Req'd

EU Panel Follows FDA's Lead On Wegovy, Recommending Use to Prevent Cardiac Events

(7/25, Max Bayer, Endpoints News) ...The EU's Committee for Medicinal Products for Human Use (CHMP) recommended that Wegovy's label be expanded, more than four months after the FDA approved the cardio-focused addition...With CHMP's blessing, Novo expects the European Medicines Agency to update the label within a month. The company says that while the exact mechanism of action resulting in reduced cardiac risks is unknown, it's "likely multifactorial."... Full

EU Medicines Regulator Rejects Eisai-Biogen Alzheimer's Drug

(7/26, Manas Mishra and Puyaan Singh, Reuters) ...The European Union's drugs regulator on Friday rejected Eisai and Biogen's breakthrough treatment for early Alzheimer's disease, in a blow to the drugmakers as take-up in the U.S. has been slower than expected. The agency's Committee for Medicinal Products for Human Use had recommended not granting an authorization as the observed benefits did not counterbalance the risk of serious side events, especially brain swelling and bleeding or microhemorrhages... Full

UK MHRA Issues Landmark Infringement Notice To Celixir Over Serious Clinical Trial Violations

(7/25, Eliza Slawther, Pink Sheet) ...The UK's drug regulator said that a trial run by cell therapy firm Celixir "risked seriously jeopardizing the rights, safety and wellbeing of trial participants" after an inspection discovered expired product batches, unauthorized dosing and other serious breaches... Sub. Req'd

Pharma & Medical Devices Industry Underscore Efforts to Tackle Misinformation On Labels As US FDA Issues Related Norms

(7/26, Pharmabiz.com) ...The Indian pharma and medical devices sectors are emphasising the need to address misinformation in labelling as the US FDA has issued related norms. The US FDA draft guidance responds to common queries firms have when voluntarily addressing misinformation about approved products... Full

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