Tuesday, December 3, 2024

BofA Securities Reiterates Buy Rating On Teva Pharma (TEVA)

(12/3, StreetInsider.com) ...BofA Securities analyst Jason Gerberry reiterated a Buy rating and $23.00 price target on Teva Pharma. The analyst comments "Our review of 2025 product swing factors leaves us increasingly confident Teva can deliver another year of strong (mid-SD%) revenue and EBITDA growth...We have been encouraged by recent utilization trends for Uzedy, Austedo and biosimilars and look to 2025 performance to further support (upward) estimate revisions needed to fully mitigate drags on growth from Gx Revlimid cliff (2026+)..."... Sub. Req’d

BIOSECURE Nudges Celltrion's Jump Into CDMO Business

(12/2, Jung Whon Shin, Generics Bulletin) ...Group chairman Jungjin Seo talked to investors about these and other plans at a recent meeting in Hong Kong, assuring them of a rosy business outlook and growth expectations. Aside from the expansion of the biosimilars business and Zymfentra (subcutaneous infliximab biosimilar), he also spent time explaining the rationale and plans behind the establishment of the CDMO subsidiary this month... Global Sub. Full

Novartis to Pay $1 Billion Upfront to License Huntington's Drug from PTC

(12/2, Andrew Joseph, STAT Plus) ...Novartis is paying $1 billion upfront in a licensing deal for an experimental Huntington's disease treatment from PTC Therapeutics, the companies said Monday. The agreement also includes another $1.9 billion in possible payments if certain development, regulatory, and commercial milestones are hit. "This agreement with PTC is intended to bolster our neuroscience pipeline and reflects our strategic focus and commitment to explore new and potentially transformative approaches for neurodegenerative diseases with high unmet needs," Vas Narasimhan, the CEO of Novartis, said in a statement... Sub. Req’d

Novartis in Up to $2.9 Billion Licensing Deal for PTC Therapeutics Huntington's Disease Drug

(12/2, Mariam Sunny, Reuters) ...Novartis will take over the development, manufacturing, and sales of the oral drug after the completion of the ongoing portion of the mid-stage study, PTC said. Currently available treatments, including Neurocrine Biosciences' Ingrezza and Israel-based Teva Pharmaceutical's Austedo, only treat the symptoms associated with the disease but cannot stop or reverse it... Full

AstraZeneca India MD Says Pact With Mankind Pharma Helped Boost Asthma Drug's Reach

(12/3, NDTV Profit) ...AstraZeneca Pharma India Ltd.'s deal with Mankind Pharma to distribute asthma drug Symbicort is helping the company reach more patients across the country, according to Sanjeev Panchal, the drugmaker's India president and managing director...Talking to NDTV Profit about the agreement, Panchal noted that the Indian arm of AstraZeneca is bringing "innovative medicines" to the country, but it needs to be distributed to a larger population... Full

Efficacy of Vyepti Highlighted by New Clinical Trial Results in Severe Migraine

(12/3, Lundbeck) ...New results from the RESOLUTION trial demonstrate the efficacy of Vyepti® (eptinezumab) on top of patient education for patients severely impacted by migraine, with the placebo-controlled Phase IV trial finding that patients with chronic migraine and medication-overuse headache rapidly benefit from treatment with Vyepti... Full

Exclusive: Novo Nordisk India Execs Urge Early Wegovy Launch as Weight-Loss Rival Looms

(12/3, Leroy Leo and Rishika Sadam, Reuters) ...Officials at the Danish drugmaker have said Wegovy might be introduced in India in 2026 once regulatory approvals are in hand and there is sufficient supply. More recently, Novo's India team proposed moving the launch to next year, around the same time Lilly is expected to introduce its weight-loss drug Mounjaro. In a closed-door meeting at Novo's Denmark headquarters about two months ago, the India team raised concerns that the company could lag behind Lilly in the domestic market if Wegovy was not launched early, said one of the sources, who spoke on condition of anonymity as they were not authorized to speak to the media... Full

Race for Approval of First Oral GLP-1R Drug in Obesity Intensifies with Four in Phase III Trials: GlobalData

(12/2, Express Pharma) ...In recent years, GLP-1 receptor (GLP-1R) products have gained immense popularity. Currently, four innovative GLP-1Rs are approved worldwide for obesity, all of which are injectables. This leaves a gap in the obesity market for an oral GLP-1R product. 63 drugs are in active development, with four Phase III products racing to earn the inaugural approval in this untapped market, says GlobalData... Full

Big Pharma's Bet On China Biotech Is a Rare Trade Bright Spot

(12/2, Amber Tong and Ashleigh Furlong, Bloomberg) ...The current need to replenish portfolios is particularly stark as Big Pharma stares down patent expirations through 2030 on treatments for cancer, inflammatory disease and other conditions. The so-called patent cliff could jeopardize between $180 billion and $360 billion in annual sales, analysts estimate. Executives at some major drugmakers have placed a bigger emphasis on blockbusters – medicines that could bring in at least $1 billion in annual revenue. The track record of China's homegrown therapies on the global stage is limited so far... Full

Perceptions of Biosimilar Switching Among Veterans With IBD

(12/2, Deana Ferreri, PhD, The Center For Biosimilars) ...Findings of a study using deliberative sessions to assess patient perceptions found that veterans with inflammatory bowel disease have concerns about the relative risks and benefits of switching and view physician-patient communication, transparency, shared decision making, and individualized care as important considerations. Participants favored approaches that would switch patients with the most severe disease last and those that would offer patients more control of biosimilar switching... Full

Cancer Drug Prices Rise in the US Post-Launch, Fall in Germany, Switzerland

(12/2, Brooke McCormick, AJMC) ...US cancer drug prices increased post-launch, while Germany and Switzerland saw decreases for both cancer and noncancer drugs. Median launch prices of cancer drugs were significantly higher than noncancer drugs in all three countries. Post-launch, US drug prices increased by 0.4% annually, with cancer drugs rising 1.7% and noncancer drugs decreasing 0.8%. Germany and Switzerland experienced annual post-launch price decreases of 5.8% and 3.4%, respectively, for both drug categories. The study highlights the importance of addressing both launch and post-launch price changes to improve drug access... Full

Respiratory Illness Season Begins to Ramp Up Now. Here's What's Already Starting to Hit

(12/2, Deidre McPhillips, CNN) ...Overall, the US Centers for Disease Control and Prevention predicts that this season could be similar — or even better — than the last, but the peak rate of respiratory virus hospitalizations will likely be well above what they typically were in years before the Covid-19 pandemic. For now, though, Covid-19 levels in the US are nearly the lowest they've been since the start of the pandemic and they're decreasing, according to CDC data from December 2. Wastewater data suggests that flu and respiratory syncytial virus, known as RSV, are also circulating at low levels but emergency department visits for both viruses have started to rise... Full

Trump's Tariff Proposal May Impact Prices of Medical Devices, Generic Drugs

(12/2, Lecia Bushak, MM+M) ...Trump's proposed tariffs could affect 75% of all available U.S.-marketed medical devices because they're manufactured overseas, according to the report. The move could negatively impact the medical devices market given the growing aging population and the rise of chronic illnesses, according to Aidan Robertson, medical analyst at GlobalData... Full

Legislators Urge DOJ to Investigate PBMs for Potential Role in Opioid Epidemic

(12/2, Paige Minemyer, Fierce Healthcare) ..."Recent reports, including confidential files and information from CVS Caremark, Express Scripts and Optum Rx, suggests the three largest PBMs colluded and conspired to steer patients towards Oxycontin in exchange for $400 million," the legislators wrote. The allegations stem from an October article in Barron's that details the findings. The outlet reported that these three firms secured the $400 million in rebates and fees from Purdue Pharma across a yearlong period ending in late 2017. Barron's also reported that the PBMs in question largely pocketed the rebates rather than passing those savings on to consumers, according to the letter... Full

Drug Prices Negotiated by Medicare Still Higher Than Other Countries'

(12/2, Shannon Firth, MedPage Today) ...Compared with their net prices prior to negotiation, negotiated prices for the 10 drugs ranged from 8% lower for dapagliflozin (Farxiga) to 42% lower for sitagliptin (Januvia), reported Olivier J. Wouters, PhD, of the London School of Economics and Political Science, and co-authors... Full

The Real Reasons Drug Prices Are So High

(12/2, Murray Ross Anthony Barrueta, Health Affairs) ...What's missing from the public policy debate about drug prices is an understanding of how pharmaceutical R&D - including the establishment and transfer of intellectual property rights - and the drug market have changed over the past 45 years. These changes, driven principally by a handful of laws described below, have brought new research organizations and investors into the R&D process, increased industry's pricing power and its willingness to use it, and diminished private purchasers' negotiating power. Understanding this 'new' R&D ecosystem is important for effective policymaking... Full

FDA Defends Increased Use of Guidance in New Report to Congress

(12/2, Zachary Brennan, Endpoints News) ...The FDA is defending its increased use of non-binding guidance documents rather than legally-enforceable rulemakings, arguing that guidance can better keep pace with the latest science. The report to Congress, issued Monday as part of the 2023 congressional appropriations, says that FDA has "significantly increased the number of guidance documents it publishes annually," but adds that "issuing guidance documents makes FDA's recommendations accessible and transparent, facilitates consistency, and prevents unnecessary expense and delay in product development."... Full

FDA Issues Reports On Best Practices for Communication, Guidance Development

(12/2, Ferdous Al-Faruque, Regulatory Focus) ...The US Food and Drug Administration has issued two reports detailing its actions and plans for best practices for communication with interested parties and for issuing guidance documents. The agency's thinking in both areas was influenced by its actions during the COVID-19 pandemic, and both reports were mandated by Congress in the Consolidated Appropriations Act of 2023... Full

Quiet On the Set? Forbidding FDA To Take Photographs During An Inspection Can Be Regrettable

(12/2, Douglas B. Farquhar, FDA Law Blog) ...Don't tell Investigators they can't take pictures. Ask them why they think they are entitled to take pictures, ensure that what they are photographing is within the scope of their inspection powers, and then take side-by-side photographs so you can demonstrate later if the FDA photos are misleading. If you want to challenge FDA investigators for being outside of their inspectional authority, prepare to address an observation in a Warning Letter. Unfortunately, multiple courts have held that Warning Letters are not final agency action, so it may be hard to judicially challenge FDA's authority to take photographs during an inspection... Full

New York Adopts New Market Conduct Regulations For PBMs

(12/2, Sigi Ris, InsideHealthPolicy) ...The New York State Department of Financial Services has adopted new market conduct regulations for pharmacy benefit managers in the state, including requirements that prohibit steering of patients to larger PBM-affiliated pharmacies, prohibit retroactive reimbursement adjustments and ensure drugs can be delivered to homes... Sub. Req’d

‘We're 40 Years Behind Them And The Gap Is Growing' – Burt Calls For European Urgency On Value Added Medicines

(12/2, Dave Wallace, Generics Bulletin) ...At Medicines for Europe's annual conference earlier this year, the association's value added medicines sector chair and Pharmanovia CEO, James Burt, set out a stark message for the region – suggesting that it was falling behind other global markets by not harnessing the potential of reformulated medicines... Global Sub. Full

Antibiotic Breakthrough from India Can Counter Drug-Resistant Bacteria

(12/2, Daphne Clarance, India Today) ...Nafithromycin is India's first indigenous antibiotic to counter multi-drug-resistant pathogens. It will be used in the treatment of drug-resistant pneumonia. It is 10 times more effective than azithromycin...With Nafithromycin's introduction, experts believe, it could provide a "much-needed relief" against resistant pathogens... Full

India Regulatory Reform: ‘Redeliberation' At SECs Tightened, ‘Unnecessary Load' Reduced

(12/3, Anju Ghangurde, Pink Sheet) ...Addressing the annual summit of the Organisation of Pharmaceutical Producers of India (OPPI), Dr Rajeev Raghuvanshi, Drugs Controller General of India (DCGI), outlined certain initiatives that the regulator is implementing to ensure optimal use of resources, while also seemingly tightening some processes around areas like clinical trial clearances. The OPPI essentially represents the interests of foreign firms in India... Global Sub. Full

Strategic Impacts of India's Biotech Revolution On Global Pharma

(12/3, Aditya Sharma, Hindustan Times) ...With a strong foundation in research, innovation, and government support, India's biotechnology sector has emerged as a critical player on the global stage. This growth not only bolsters the country's position as a bio-innovation hub but also lays the groundwork for addressing complex challenges, from health security to sustainable development. According to the India BioEconomy Report of 2022, the biopharma segment is the largest contributor to the nation's biotech industry, accounting for 49% of the market and generating around $39.4 billion in 2021... Sub. Req’d

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