Tuesday, January 14, 2025

Teva CEO On Drug Pricing, Generics, Supply Shortages

(1/13, Bloomberg) ...Teva Pharmaceuticals CEO Richard Francis reflects on company performance in 2024, drug pricing, getting more drugs to market and supply shortages of the drug Adderall. He speaks to "Bloomberg Open Interest" from the JPMorgan Healthcare Conference... Full

How Teva Pharmaceuticals is Thinking About Trump's Return: CEO

(1/13, Seana Smith and Madison Mills, Yahoo! Finance) ...Teva Pharmaceuticals CEO Richard Francis joins Seana Smith and Madison Mills on Catalysts to discuss what both the pharmaceutical company and industry at large are expecting from Trump's return to the White House. Francis says Teva has not made any changes to its business operations before Trump's second inauguration, and is waiting to see how Trump's policy promises will play out. "I think the way Teva thinks about it is whichever administration comes into the US, we've shown a track record of being able to work with them effectively," the CEO explains... Full

JP Morgan Week 2025 - Day 1

(1/13, Jonah Comstock, Pharma Phorum) ...There were no deals larger than $5 billion in 2024, Margolis says, so it's exciting that 2025 has already included a $14 billion deal. But is this the beginning of a trend? McDonald and [Konstantina Katcheves, SVP, Innovative Medicines Global Business Development and Acquisitions, Teva Pharmaceuticals,] both say yes-- it's going to be a year of bigger deals..."How you deploy that dry powder is going to depend on the opportunity. There's going to be a flexibility in deal types across the board, it's just the bigger ones last year just weren't there," Katcheves says. "I think there were macro factors, like uncertainty about an upcoming election, that effected that."... Full

JJPM25, Day 1: Pfizer CEO Discusses Plan to Overcome $17B 'LOE Wave'

(1/13, Fraiser Kansteiner, Angus Liu, Ben Adams, Kevin Dunleavy, Zoey Becker, Eric Sagonowsky, Fierce Pharma) ...Coming off a protracted rough patch in 2023, generic and innovative medicines hybrid Teva Pharmaceutical Industries has busied itself in recent years executing on CEO Richard Francis' "Pivot to Growth" strategy, which has subsequently helped the company achieve 7 straight quarters of revenue growth...Two years into the corporate overhaul, Francis said Teva is on track to deliver on his strategy's 2027 targets, which hinge on the launch of new innovative drugs like the company's long-acting injectable version of the atypical antipsychotic olanzapine, plus continued growth of Teva's biosimilar portfolio... Full

Teva Strikes Two Major Deals For Eculizumab And Aflibercept Biosimilars

(1/13, Dave Wallace, Generics Bulletin) ...Teva has bolstered its biosimilars business with a pair of alliances that will give the Israeli off-patent giant rights to Samsung Bioepis' Soliris (eculizumab) rival in the US and Formycon's version of Eylea (aflibercept) in Europe. The deal with Samsung Bioepis will see the Korean firm develop, register, manufacture and supply its Epysqli (eculizumab-aagh) for the US market to Teva, which will be responsible for commercialization... Global Sub. Full

Teva Inks Strategic Collaboration with Klinge & Formycon to Commercialize Formycon's Biosimilar Candidate to Eylea in Major Parts of Europe and Israel

(1/14, Pharmabiz.com) ...Richard Daniell, executive vice president, European Commercial at Teva said: "We are excited to extend our collaboration with Formycon, reinforcing the solid foundation that commenced with the commercialization of ranibizumab biosimilar (Ranivisio/Ongavia) in Europe. The collaboration expands Teva's broad biosimilar portfolio and again demonstrates our firm commitment to creating greater access to quality innovative medicines to the benefit of patients and the healthcare systems we serve."... Full

Apotex Remains Alert To Acquire US Provigil And Nuvigil Rights

(1/14, Dean Rudge, Generics Bulletin) ...A decade after Teva was slapped with a ten-figure fine for its alleged illegal activities blocking US generic competition to its Provigil brand, the Israeli firm has offloaded the narcolepsy drug and follow-up brand Nuvigil in the US to Apotex...Marking a "strategic milestone for Apotex and a significant initial step in growing our US specialty business," the Canadian firm has announced that its affiliate Nuvo Pharmaceuticals has bought up the US rights to the treatments of excessive daytime sleepiness in adults with narcolepsy... Global Sub. Full

Sandoz: Global Generics And Biosimilars Market To Grow At 7% Annual Compound Rate For Next 10 Years

(1/14, RTT News) ...Sandoz Group AG, a Swiss generic and biosimilar medicines maker, Tuesday announced that the global generics and biosimilars market, which is worth more than $200 billion in gross sales, is expected to grow at an annual compound rate of 7% for the next 10 years. For Sandoz, biosimilars are now its single-biggest growth driver. Sandoz also said it is on track with its plans for further biosimilar launches, including four in 2025... Full

Will MSN Push On With US Generic Entresto Launch By The Week's End?

(1/13, Dean Rudge, Generics Bulletin) ...Novartis has been spooked by the potential for MSN Laboratories to launch its generic version of the originator's $3bn Entresto (sacubitril/valsartan) heart failure brand, filing an emergency motion in an appeals court in Washington DC just days ahead of the proposed expiry of one of Entresto's US patents... Global Sub. Full

AstraZeneca Sues to Block MSN Labs' Copy of Cancer Drug's Tablet

(1/13, Christopher Yasiejko, Bloomberg Law) ...Copies of AstraZeneca Plc's Calquence tablets proposed by MSN Laboratories Pvt. Ltd. infringe two patents for the blood-cancer treatment, according to a federal lawsuit filed six months after MSN settled a case over the blockbuster drug's capsule formulation... Sub. Req’d

After a 'Reset' Year for M&A, Expect Bigger Deals in 2025: Reports

(1/13, Kevin Dunleavy, Fierce Pharma) ...While there was plenty of M&A activity in 2024, recent deals have been "smaller, smarter and more agile" than those in years past, according to EY's Firepower report: life sciences dealmaking—trends in 2025. In its own recent M&A report, PwC predicted that falling interest rates and more post-election certainty about the macroeconomic landscape will help spur larger deals in 2025... Full

Healthcare Dealmakers Eye M&A Resurgence in Second Trump Term

(1/13, Sabrina Valle, Reuters) ...Seventeen healthcare dealmakers who spoke with Reuters were unanimously optimistic about an M&A recovery after a slowdown last year when no biopharma transactions above $5 billion closed in the sector for the first time in at least a decade. In an early sign of the recovery in dealmaking, Johnson & Johnson on Monday clinched a $14.6 billion deal to buy neurological drugmaker Intra-Cellular Therapies... Full

Unexpected Twist: Pharma Mergers May Reduce Drug Prices

(1/13, Tom Snee, Medical Xpress) ...The study finds the price drops are due to cost savings achieved by merging firms that have overlapping products that treat the same medical condition. These results, published in the Journal of Corporate Finance, did find that industry-leading firms like Eli Lilly and Pfizer that focus on novel, first-in-class drugs raised the price of overlapping drugs by 6.3% after mergers... Full

GSK CEO Optimistic About Dealmaking, Trump Administration

(1/14, Ashleigh Furlong, Antonia Mufarech and Katie Greifeld, Bloomberg) ...GSK Plc's Chief Executive Officer Emma Walmsley is looking to do more deals as the British drugmaker doubles down on its return to cancer medicines. While GSK already agreed to multiple deals in 2024 and announced an agreement for cancer biotech IDRx Inc. for as much as $1.15 billion on Monday, "you should expect more from us," Walmsley said in an interview with Bloomberg TV... Sub. Req’d

Pfizer Going 'All In' On Obesity Drug Development, CEO Bourla Says

(1/13, Bhanvi Satija and Michael Erman, Reuters) ...U.S. drugmaker Pfizer is going "all in" to develop its experimental obesity drug and has been recruiting more experts in that area, Chief Executive Officer Albert Bourla said at the JPMorgan Healthcare Conference on Monday. Bourla said the experts were helping Pfizer "make better and more sound decisions," and the company could start a late-stage study of its drug, danuglipron, in the second half of this year... Full

Eli Lilly Scientific Chief Skovronsky Says Scorpion Deal ‘Checked All The Boxes'

(1/13, Matthew Herper, STAT+) ...Eli Lilly's chief scientific officer said Monday that the company purchased a cancer drug from the startup Scorpion Therapeutics because Scorpion's drug appeared better than similar molecules it had been working on itself. "This is an example of a target that we've been working on ourselves for years," said Daniel Skovronsky, the Lilly CSO, in an interview near the annual J.P. Morgan Healthcare Conference. The Scorpion drug, he said, has a high selectivity for the mutant form of a protein found in some cancers, without targeting the normal version found in healthy cells... Sub. Req’d

Samsung Biologics Secures Largest-Ever Deal with European Pharma Giant

(1/14, Kim Kae-yeon, The Korea Herald) ...Samsung Biologics has kicked off the start of 2025 with the largest single contract in the company's history, signing a record-breaking $1.41 billion deal, amounting to some 40 percent of the total orders received last year. On Tuesday, the company disclosed that it had signed a large-scale contract manufacturing organization agreement with a European pharmaceutical company. The contract runs until Dec. 31, 2030. The client company and details of the signed drug product remain confidential... Full

After Alkermes' Makeover, CEO Richard Pops Touts its Pipeline Program and Rare Biotech Model

(1/13, Kevin Dunleavy, Fierce Pharma) ..."If you look behind the curtain, we've maintained a basic market cap of four to five billion, while completely changing the business underneath it," Richard Pops, Alkermes' chairman and CEO, said in an interview with Fierce Pharma...While the bulk of Alkermes' revenue was once royalty- and manufacturing-based and came in part from its innovative drug delivery technology, it's now reliant on neuroscience products that it develops and sells on its own... Full

Bayer's Head of Pharma Oelrich Expects Business to Return to Growth in 2027

(1/13, Connor Hart, The Wall Street Journal) ...Bayer expects its pharmaceutical business to return to growth in 2027, unit President Stefan Oelrich said Monday. The German conglomerate is planning to launch new therapies — one that treats a rare heart disease, as well as a non-hormonal treatment for symptoms of menopause — later this year. It hopes these new drugs will offset falling sales of its blockbuster blood thinner Xarelto, which pulled in about $4 billion annually before it last year began losing its exclusivity and facing generic competition... Sub. Req’d

Drugmakers Will Ask Trump to Pause Price Negotiations

(1/13, Madison Muller, Cynthia Koons and Josh Wingrove, Bloomberg) ...Eli Lilly & Co. said it and other drugmakers will ask the Trump administration to pause drug-price negotiations, even as Biden-appointed officials prepare a new list of medicines that should be targeted. "They need to fix it" before negotiating down the price of more drugs, Lilly Chief Executive Officer Dave Ricks said on the sidelines of the JPMorgan Healthcare Conference in San Francisco, referring to the Inflation Reduction Act... Sub. Req’d

PhRMA Asks Court for Quick Win in Revived US Drug Price Suit

(1/13, Nyah Phengsitthy, Bloomberg Law) ...The Pharmaceutical Research and Manufacturers of America, along with co-plaintiffs the National Infusion Center Association and the Global Colon Cancer Association, is urging the US District Court for the Western District of Texas to agree with its claims that the Medicare Drug Price Negotiation Program is unconstitutional... Sub. Req’d

Hickenlooper, Cotton, Welch, Collins Reintroduce Skinny Labels, Big Savings Act to Safeguard Generic Drugs, Slash Drug Prices

(1/13, U.S. Senator Hickenlooper for Colorado) ...Last week, U.S. Senators John Hickenlooper, Tom Cotton, Peter Welch, and Susan Collins reintroduced the bipartisan Skinny Labels, Big Savings Act, a bill designed to lower drug prices by accelerating the roll-out of generic drugs and creating legal protections from endless lawsuits for generic drug manufacturers who obtain "skinny label" FDA approvals. The senator previously introduced the legislation in the 118th Congress... Full

E&C Adds Members With PBM Reform History

(1/13, Sigi Ris, Inside Health Policy) ...Three of the new Democrats joining the House Energy & Commerce Committee are strong proponents of pharmacy benefit manager reform: Reps. Alexandria Ocasio-Cortez (NY), Jake Auchincloss (MA) and Greg Landsman (OH). E&C will also add the following additional Democrats: Reps. Troy Carter (LA), Rob Menendez (NJ), Kevin Mullin (CA) and Jennifer McClellan (VA)... Sub. Req’d

Defiant, Pfizer CEO Talks About Trump, Obesity Drugs, and the ‘Pfizer Machine'

(1/13, Matthew Herper, STAT+) ...In on-stage comments earlier in the day at the conference, [Pfizer CEO Albert Bourla], who has met with President-elect Trump, said that he believes that potential upsides of a Trump administration for the pharmaceutical industry outweigh the downsides...Bourla said that he expects Trump to sign many executive orders as soon as he takes office, but does not know what they will be or whether they will affect the pharmaceutical industry... Sub. Req’d

Former Trump FDA, CMS Heads Lay Out How His Return Could Reshape Health Policy

(1/14, Jonathan Wosen, STAT+) ...Scott Gottlieb and Seema Verma, the former heads of the Food and Drug Administration and Centers for Medicare & Medicaid Services, respectively, said that the incoming president and his team could influence which vaccines get recommended and take steps that discourage states from requiring certain vaccines for school children. The former Trump appointees added that he'll likely target pharmacy benefit managers, much-maligned middlemen in drug pricing negotiations, and may look for ways to cut costs within Medicaid and Medicare Advantage... Sub. Req’d

Trump's US FDA Reforms Need Center Director, Staff Support To Succeed, Former Leaders Say

(1/13, Sue Sutter, Pink Sheet) ...Current and former FDA leaders said the incoming administration's plans are more likely to succeed if they are built on existing agency efforts and supported by staff and the center directors. Price competition, fewer development hurdles for small companies, and a streamlined path to demonstrating substantial evidence of effectiveness in very rare diseases could be among the new administration's early priorities. The former FDA leaders' discussion occurred the same weekend that BIO's CEO met with Trump representatives to discuss FDA reforms... Global Sub. Full

High Court Rejects Vanda Suit Over Medicaid Drug Definition

(1/13, Nyah Phengsitthy, Bloomberg Law) ...The US Supreme Court declined Monday to take up a challenge from Vanda Pharmaceuticals Inc. over what constitutes a "line extension" drug under the federal government's Medicaid Drug Rebate Program... Sub. Req’d

New Year, Same Fact: PBMs Play Critical Role Driving Down Health Costs

(1/13, PCMA) ...PBMs work for employers and health plans to secure savings on prescription drugs, enable better health outcomes for patients, and support access to quality prescription drug coverage for more than 275 million patients. PBMs help employers and patients save, on average $1,040 per person per year, providing $145 billion in overall value to the health care system annually. The vast majority of employers voluntarily choose to hire PBMs to help drive down health care costs. A recent survey of nearly 700 employers across the country conducted by NORC at the University of Chicago found that employers are overwhelmingly satisfied with PBMs' transparency, flexibility, and savings... Full

Industry Voices—Why the Great Unraveling of PBMs Will Accelerate in 2025

(1/13, Matthew Gibbs, Fierce Healthcare) ...The pharmaceutical supply chain is a sector infamous for glacially slow adjustments, lackluster reform, lack of transparency and massive anti-competitive conglomerates. Years of dominance by the three major vertically-integrated pharmacy benefit managers that control the bulk of the market have placed great strain on the healthcare industry. However, a recent confluence of events marks the first time in decades that I've seen any indication of real, meaningful change to the system... Full

FTC Decided Not to Block An Acquisition that Could Impact Supply and Prices of Important Medicines.

(1/13, Patricia Kelmar, PIRG) ...After 8 months of investigating the proposed acquisition, the FTC ultimately decided not to act to block the vertical integration of these companies. We're frustrated that the agency did not decide to intervene on behalf of the public to prevent the acquisition to avoid the potential for anticompetitive practices in the wake of the merger. We'll be watching for the possible consequences: higher prices for GLP-1s, disruptions in access to other drugs or Novo Nordisk competitors and new moves by more drug companies to buy up their own CDMOs to block competitors and improve their bottom line by raising prices... Full

Innovation Drives Divergence: US FDA Drugs and Biologics Centers Follow Own Trajectories

(1/13, Bridget Silverman, Pink Sheet) ...Regenerative medicine accounted for eight of the US FDA biologics center's 11 novel approvals in 2024, reflecting a major shift in product composition over only a few years. The FDA drug center's 50 approvals contained a smaller percentage of products qualifying for expedited review programs and orphan drug designation than the biologics center's 2024 cohort. First-cycle approvals were a notably low percentage of the CDER approval cohort, while first-in-class drugs came in high... Global Sub. Full

Patient Groups Call On Trump Administration to Let Medicare Cover Obesity Drugs

(1/13, Nathaniel Weixel, The Hill) ...Led by the Obesity Care Advocacy Network (OCAN), more than 70 organizations said in a statement that addressing, treating and managing obesity is key to making America healthier. The groups pointed to a study that found if nothing is done, 213 million Americans will be overweight or obese by 2050. That would mean hundreds of millions of people facing health complications like diabetes, cancer, heart problems, breathing issues and mental health challenges... Full

US FDA Guidance Redefines Obesity, But Keeps 2007 Efficacy Standard

(1/13, Michael McCaughan, Pink Sheet) ...New FDA draft guidance on obesity drug development defines the condition as a disease for the first time. The change means that potential clinical trial patients no longer must fail a diet and exercise program before enrolling. But expectations for demonstrating efficacy and several other recommendations were unchanged from 2007 draft guidance... Global Sub. Full

IGBA Welcomes New Chair and New Full Member

(1/13, International Generic and Biosimilars Medicines Association) ...IGBA, the International Generic and Biosimilar Medicines Association (IGBA), representing global manufacturers of generic and biosimilar medicines, announced today that Shinichiro Hirose, Director of International Affairs at the Japanese Generic Medicines Association (JGA) is taking over the position of IGBA Chair for 2025 from Adrian van den Hoven, Director of Medicines for Europe. Jim Keon, President of the Canadian Generic Pharmaceutical Association, will take over the position of IGBA Vice-Chair for 2025... Full

Game-Changing EU-Level HTA Regs Must Allow For Lessons To Be Learned

(1/13, Francesca Bruce, Pink Sheet) ...The landmark Health Technology Assessment (HTA) Regulation and the EU-level joint clinical assessments (JCAs) that represent a huge shift in the region's pricing and reimbursement landscape became applicable on January 12,. The pharmaceutical industry says that any kinks in the new system must be ironed out as quickly as possible, even ahead of the 2028 planned review of the procedures... Global Sub. Full

EU Consultation Deadline Looms For Pharmacovigilance Rules Update

(1/13, Eliza Slawther, Pink Sheet) ...Stakeholders have until January 15, to respond to a European Commission proposal that aims to harmonize pharmacovigilance activities by marketing authorization holders, national competent authorities and the European Medicines Agency... Global Sub. Full

Centre Steps Up Pace of Generic Drug Stores; One Jan Aushadhi Kendra Launched Every Two Hours

(1/13, Priyanka Sharma, Mint) ...The scheme to open many more Jan Aushadhi Kendras is being implemented through the Pharmaceuticals & Medical Devices Bureau of India (PMBI) and is aimed at reducing out-of-pocket expenditure for medicines, the bureau's CEO Ravi Dadhich said in an interview. The plan, part of the government's Jan Ausjhadhi Pariyojana, involves setting up 25,000 generic drug stores by 2027. Around 14,600 stores are operational in as of now. Till March this year, the government aims to surpass the target of 15,000-plus Kendras... Sub. Req’d

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