Wednesday, June 5, 2024

Teva Pharma (TEVA) PT Raised to $21 at Barclays

(6/5, StreetInsider.com) ...Barclays analyst Balaji Prasad raised the price target on Teva Pharma to $21.00 (from $20.00) while maintaining a Overweight rating... Sub. Req'd

Teva Price Target Raised to $21 from $20 at Barclays

(6/5, The Fly) ...The analyst is "incrementally positive" on Teva's research and development progress, with growth led by biosimilars... Full

India Becomes the Largest Supplier of Drugs to Russia

(6/4, The Pharma Letter) ...India has become the largest supplier of drugs to the Russian market, overtaking Germany, which had been in the lead for the last two years, reports The Pharma Letter's Russia correspondent...Of the major foreign drug suppliers to Russia is Israeli generics giant Teva Pharmaceutical Industries. According to RNC Pharma, in 2023 Teva imported 149.8 million drug packages to Russia, which is11% more than a year earlier... Sub. Req'd

U.S. Drug Shortages Reach Decade-High and Last Longer

(6/4, U.S. Pharmacopeia) ...The U.S. Pharmacopeia released its inaugural Drug Shortages Report today that shows drug shortages in the United States persisted over the past decade, exposing market vulnerability and repercussions that impact patient care. The report, encompassing trends up to the end of 2023 in the United States, reveals that shortages lasted longer—the average drug shortage lasts for over three years compared to about two years in 2020—and impacted a wide range of therapeutic classes. More than half, 53 percent, of new drug shortages were generic sterile injectable medicines... Full

U.S. Drug Shortages Have Reached a Decade High and Are Lasting Longer, Too

(6/4, Ed Silverman, STAT Plus) ...A key culprit, according to U.S. Pharmacopeia, often are thin profit margins. "Economic pressures, especially the very low prices that generics manufacturers recover for many medicines, along with contracts that are frequently broken, have left our generic medicine supply chain fragile," said Anthony Lakavage, senior vice president for global external affairs, in a statement. This is the second recent report to note shortages have grown particularly troublesome... Sub. Req'd

Finding Solutions to Decades of Cancer Drug Shortages in Spotlight at Annual Meeting

(6/4, ASCO) ...The American Society of Clinical Oncology hosted a panel discussion focused on finding solutions to the crisis of cancer drug shortages at the 2024 ASCO Annual Meeting...The session touched on mitigation strategies, such as increasing supply chain visibility, and ways to better monitor and identify impending shortages and drugs at high-risk of shortage, while avoiding panic buying. Most of the discussion, however, focused on preventing cancer drug shortages by addressing key economic factors in the generic drug market to improve its resiliency... Full

Rx Drug Shortages Hit All-Time High, Affecting Prices

(6/4, Zach Myers, CBS 4 Indianapolis) ...There have been more prescription medication shortages reported this year than ever before. There are currently nearly 250 prescription drugs on the nation's drug shortage list. The shortages are affecting 22 different therapeutic categories. Those include diabetes medications, ADHD medicines, chemotherapy drugs, narcolepsy medication, and pain and sedation drugs. There are several different reasons for the different shortages. While shortages of diabetes drugs may be from increased demand, other shortages can be caused by manufacturing problems still lingering from the COVID-19 pandemic. They can also happen when drug manufacturers simply stop making a certain drug... Full

GSK Foresees Supply Shortage of Asthma Inhaler Ventolin Nebule 2.5mg

(6/5, Yang Hyeon-su, Korea Biomedical Review) ...On Tuesday, GSK reported the expected shortage to the Ministry of Food and Drug Safety. Ventolin Nebule is used to treat severe acute asthma (treatment of persistent asthma) and chronic bronchospasm that does not respond to standard therapies...The Ventolin Nebule 2.5 mg supply shortage is expected to begin on Aug. 1... Full

Torrent Spells Out Ambitions For $300M Business In The US

(6/5, Dean Rudge, Generics Bulletin) ...Torrent Pharmaceuticals will continue to aim towards returning to profitable growth in the US, with a basket of eight "on-time approvals coming this year," which the Indian firm anticipates in the medium term will help it towards a total US business worth between $250m and $300m in annual revenues... Global Sub. Full

Sun-Taro Merger Nearing Completion As Shareholders Vote Yes

(6/4, Urte Fultinaviciute, Generics Bulletin) ...Sun Pharma will finally merge with Taro as a single company, after failed attempts to absorb the firm over a decade ago. Also, the firm hints about its upcoming generic portfolio, including GLP-1 products, as well as increasing investment into its specialty business...In the financial year ahead, Sun Pharma expects to see a high single-digit consolidated topline growth for FY2025 and up its investment in R&D... Global Sub. Full

Fresenius Lifts 2024 Targets for Private Healthcare Unit Helios

(6/5, Tristan Veyet, Reuters) ...German healthcare group Fresenius raised the yearly guidance for its private healthcare provider Helios on Wednesday, following a strong start to 2024 and the conclusion of group-wide restructuring...CEO Michael Sen said in a statement that the sharpened focus on its key businesses was paying off. "The strong and reliable growth momentum of our Care Provision Platform gives us confidence which is why we are improving the outlook for Fresenius Helios for the full year," Sen added... Full

Why CEO AstraZeneca Believes the Drugmaker Can Almost Double Revenue by 2030

(6/4, Julie Coleman, CNBC) ...AstraZeneca CEO Pascal Soriot explained in a Tuesday interview with CNBC's Jim Cramer why the drugmaker believes it can almost double revenue by 2030. "Biology is complicated, and we're never sure of anything. But we have a great level of confidence we can get there, and I think this target forces us to think creatively and be ambitious and stretch," Soriot said. "But we have a large portfolio of existing products, several blockbusters ... growing strongly, and we have another 20 medicines to launch, so we should be able to get there."... Full

Hikma Opens UK Office To Strengthen Ties With NHS

(6/4, Urte Fultinaviciute, Generics Bulletin) ...In a continued effort to assert its position in the European continent, Hikma has opened a new commercial office in the UK, reinforcing its long-standing commitment to the UK's National Health Service..."Our local presence, with manufacturing facilities in Portugal, Italy, and Germany, reduces supply chain complexities and enables us to provide NHS hospitals with direct and rapid access to essential injectable medicines," said Bill Larkins, president of Hikma Injectables... Global Sub. Full

ADHD Market Set to Decline Due to Patent Expiries

(6/4, The Pharma Letter) ...The attention-deficit/hyperactivity disorder market across the seven major markets (7MM) is forecast to decline at a negative compound annual growth rate of 0.9% from $11.9 billion in 2022 to $10.9 billion in 2032. The downturn will be driven by patent expiries, high generic uptake in the largest ADHD market, namely the USS, and limited innovator entrants, according to pharma analytics company GlobalData... Sub. Req'd

Califf To Hospitals: Change Buying Practices To Stem Drug Shortages

(6/4, Maaisha Osman, InsideHealthPolicy) ...As HHS presses Congress to take legislative steps to avert drug shortages, FDA Commissioner Robert Califf is simultaneously urging hospitals to voluntarily change their buying practices to incentivize quality manufacturing and drug makers to share more information with FDA...Alan Coukell, chief government affairs and public policy officer in a non-profit generic company Civica Rx, said at the Monday meeting that stakeholders should not wait for Congress to act and instead should try to build long-term contracts that brings stability to the marketplace... Sub. Req'd

Patient Groups With Pharma Ties Call For Drug Shortage Action

(6/4, Jessica Karins, InsideHealthPolicy) ...Led by the Generics Access Project, a group composed of several patient advocacy organizations that lobbies for access to affordable generic drugs, in a letter to Congress is urging more action from lawmakers on incentivizing generic production and improving supply chain resiliency. Despite a bipartisan consensus on the importance of addressing drug shortages, legislation on the issue hasn't moved forward. The letter calls on Congress to establish models incentivizing quality and resilience in the drug supply chain... Sub. Req'd

House Lawmakers Weigh Suggestions to Fix 340B Drug Discount Program

(6/4, Dave Muoio, Fierce Healthcare) ...Legislators from both sides of the aisle appear to agree that the controversial 340B drug discount program needs refinement rather than upheaval and broadly welcomed suggestions for greater transparency and preserved access to care during a Tuesday oversight hearing. However, statements and questions from members of the Energy and Commerce Committee's Oversight and Investigations Subcommittee showed that the parties don't see eye to eye on whether the program's substantial growth reflects the hospital sector's widespread abuse of the nation's second-largest prescription drug program... Full

Bipartisan House Support Remains Elusive In 340B Reform Effort

(6/4, Cathy Kelly, Pink Sheet) ...Over the past several years, Congress has taken incremental steps toward enhancing oversight of the program and clarifying its scope. Three Republican lawmakers introduced a wide-ranging bill days before the hearing that could restrict the scope of the program, including by requiring that hospitals report how they use the revenues generated by the program. However, key Democrats raised concerns at the on June 4, hearing that those policies endanger the important support the program provides... Sub. Req'd

FDA Official Discusses Best Practice for Requesting Feedback for Combination Products

(6/4, Joanne S. Eglovitch, Regulatory Focus) ...A US Food and Drug Administration official offered advice to sponsors on best practices for requesting feedback for combination products and for submitting requests for designation (RFD) or pre-RFDs for such products at the agency's Regulatory Education for Industry Annual Conference on May 29... Full

EMA Stresses Importance Of Scientific Advice After Requests Drop 17% In 2023

(6/4, Eliza Slawther, Pink Sheet) ...The European Medicines Agency received a total of 692 requests for scientific advice and protocol assistance in 2023, down 17% from 2022 when the figure was 833. The number of requests received in 2023 was the lowest since before the COVID-19 pandemic, according to the EMA's 2023 annual report, published on May 30. There was a "significant decrease" in the number of scientific advice and protocol assistance requests submitted by pharmaceutical companies in the first half of 2023 compared with the same period in 2022, a spokesperson for the agency told the Pink Sheet... Sub. Req'd

Biopharmaceutical Industry Remains Mixed Over EU Reform Proposals, Finds GlobalData

(6/5, GlobalData) ...Reforms to the European Union's general pharmaceutical legislation emerge as one of the key policy developments affecting the operating environment for the pharma industry. In a survey, respondents' opinions on the impact of EU reform proposals were mixed, with the percentage of participants expressing positive, negative, or neutral views remaining varied, according to GlobalData, a leading data and analytics company... Full

French Pharma Lobby Unveils €2 Million Plan to Reduce Medication Misuse

(6/5, Clara Bauer-Babef, Euractiv) ...France's pharmaceutical lobby Leem unveiled a plan on Tuesday (June 4,) to fight the misuse of medicines, thought to be responsible for several thousand deaths every year, particularly among the elderly. To encourage "drug sobriety" and limit the consumption of drugs that are not necessary for patients, Leem is launching a €2 million action plan in the coming days... Full

Swiss Pilot Allows Applicants To Discuss Preliminary Drug Approval Decisions

(6/4, Ian Schofield, Pink Sheet) ...Under a new pilot being run by the Swiss regulator, Swissmedic, applicants seeking approval of a new drug or a new indication of an existing product containing a new active substance can now request a meeting to discuss any questions they have regarding a preliminary decision on approval by Swissmedic... Sub. Req'd

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