Inspectors Find Contamination At Novo Nordisk Factory Making Diabetes Drug

Bacterial contamination was detected in batches of the main ingredients for Rybelsys in a Novo Nordisk plant in North Carolina. Separately, the drugmaker is partnering with Valo health to search for new drugs using AI.


Axios Raleigh:
Contamination Found At Novo Nordisk’s Johnston County Plant, Report Says 


Novo Nordisk — the drugmaker behind the popular weight-loss drugs Ozempic and Wegovy — has been having trouble with its factory in Clayton, one of the largest employers in Johnston County. Federal inspectors discovered bacteria in batches of Novo Nordisk’s main ingredients for a diabetes drug, Rybelsus, that is made at the Clayton plant, the Wall Street Journal reports. (Eanes, 9/25)


Bloomberg:
Novo Partners With Valo Health On AI-Driven Drug Deal Worth As Much As $2.7B


Novo Nordisk A/S agreed to partner with the US technology company Valo Health Inc. to use artificial intelligence to find new drugs in a deal that could be worth as much as $2.7 billion. Valo will receive an upfront payment and a potential near-term milestone of $60 million, the companies said Monday. Closely held Valo stands to get far more if some of the 11 programs the partners will work on together reach certain mileposts. (Wienberg, 9/25)

On financial developments across the health industry —


Axios:
Alto Pharmacy Raises $120 Million In New Funding


Online pharmacy Alto Pharmacy has raised $120 million in new funding at an $800 million post-money valuation, the company confirmed to Axios. Alto is among the many late-stage startups to take a valuation cut in the current market. (Kokalitcheva, 9/25)


Modern Healthcare:
Elevance, Blue Cross Louisiana Halt $2.5B Proposed Merger


“We have chosen to withdraw BCBSLA’s plan of reorganization and Elevance Health’s acquisition application from the Louisiana Department of Insurance to provide more time for key stakeholders to understand the benefits this transaction will provide to Louisianaians and how the quality service our stakeholders know, and value will continue,” the companies said in a joint statement Monday. (Tepper, 9/25)


Reuters:
Enovis To Buy Surgical Implants Maker LimaCorporate For $850 Mln


Enovis Corp (ENOV.N), which offers orthopedic bracing, surgical implants and footcare solutions, said on Monday it had agreed to acquire Italian surgical implant manufacturer LimaCorporate for about 800 million euros ($850 million), including debt. The announcement confirmed Reuters’ report, citing people familiar with the matter, earlier on Monday.The acquisition will bolster the U.S. company’s reconstructive business, which makes shoulder, hip and knee implants used in surgeries, and expand its international footprint. (Carnevali, 9/25)


Reuters:
Artificial Heart Maker Carmat Could Run Out Of Cash After Sales Miss


French artificial heart maker Carmat (ALCAR.PA) said on Monday supply issues meant it would miss its full-year sales target and warned it could run out of cash by the end of October. “During the first half of 2023, the production ramp-up we were anticipating was significantly disrupted by supply issues,” CEO Stephane Piat said in a press release after the market close. “Due to the lack of a sufficient number of devices, we were late in generating the demand from hospitals.” (9/25)


Reuters:
AbbVie Terminates Deal With I-Mab To Develop Cancer Drug


China-based biotech company I-Mab (IMAB.O) said on Friday that AbbVie (ABBV.N) has terminated a 2020 deal to co-develop and market I-Mab’s lead cancer drug candidate lemzoparlimab. AbbVie’s decision to scrap the deal comes after it pulled the plug on an early-stage study in August last year that was testing lemzoparlimab in combination with two other drugs for treating two types of blood cancers, myelodysplastic syndrome and acute myelocytic leukemia. (9/25)


Reuters:
Exclusive: Medical Components Maker Zeus Explores $4 Billion Sale -Sources


Zeus Company Inc, a family-owned manufacturer of components used primarily in medical equipment and devices, is exploring options including a sale that could value the company at $4 billion or more, including debt, people familiar with the matter said. The Orangeburg, South Carolina-based company is in the early stages of a sale process and is working with investment bank Goldman Sachs Group (GS.N) to establish whether a deal would be financially attractive, the sources said. (Carnevali, 9/25)

In other industry news —


Bloomberg:
Amoxicillin Plant Making Strep Throat Drugs Could Shut Down


A manufacturing plant … used to make enough amoxicillin to treat the entire country’s strep throat as well as ear and other infections. At its heyday, it employed more than 500 workers and pumped out billions of pills of the most commonly prescribed antibiotic each year. But by late July, only 62 people were working at USAntibiotics LLC. Some of the plant’s equipment sat dormant, plastic draped over the machinery, and the once-bustling cafeteria was closed. Over the summer, the plant was making a mere 3% of America’s amoxicillin supply. (Swetlitz, 9/25)


Modern Healthcare:
InnovAge’s PACE Program To Grow Amid Possible Nursing Home Closures


InnovAge, the nation’s largest and only publicly traded operator of Programs of All-Inclusive Care for the Elderly, is gearing up for expansion as a proposed nursing home staffing mandate threatens to close more skilled nursing facilities. The Denver-based company operates 17 PACE centers across Colorado, California, New Mexico, Virginia and Pennsylvania. It is scheduled to open its first two PACE centers in Florida by the end of 2023 and hopes to open its first center in Kentucky and a third center in California within the next few years, according to InnovAge President and CEO Patrick Blair. (Eastabrook, 9/25)


Axios:
Costco Joins Retail Push Into Primary Care With $29 Telehealth Visits


Costco is joining big retailers’ push into primary care by offering members $29 telehealth visits, as well as lab testing and virtual mental health services. It’s part of a broad effort to use digital tools to create more customizable patient experiences that’s also drawn the likes of Amazon, Walmart, CVS and Dollar General. (Bettelheim, 9/26)


AP:
Tornado-Damaged Pfizer Plant In North Carolina Restarts Production


A major Pfizer pharmaceutical plant in North Carolina that makes critical supplies for U.S. hospitals has restarted production about 10 weeks after it was heavily damaged by a tornado, the company announced Monday. Getting a majority of manufacturing lines at the Rocky Mount facility back up and running is a “proud achievement,” Pfizer said in a statement. Full production across the facility’s three manufacturing sites is expected by the end of the year. (9/25)

In pharmaceutical news —


Reuters:
Canada’s Appili Gets US FDA Approval For Oral Antibiotic Solution


The U.S. Food and Drug Administration (FDA) on Monday approved Canadian drugmaker Appili Therapeutics’ (APLI.TO) liquid oral form of antibiotic drug metronidazole, offering an alternative to patients who have difficulty taking injections or pills. An injectable form of the drug, which is commonly used in the treatment of bacterial and parasitic infections, has been in shortage in the United States since early last year due to high demand and regulatory delays. (9/25)


NBC News:
Children’s Cancer Drugs In Shortage As Supply Crisis Continues


Pediatric cancer doctors are sounding the alarm about a growing shortage of chemotherapy drugs for children. … “It’s devastating,” said Dr. Doug Hawkins, chair of the Children’s Oncology Group, a national research organization. “Can you imagine that your child has been diagnosed with cancer, and you’re told, ‘We know how to treat this, so we have a 70% chance, an 80% chance, a 90% chance of curing your child with standard treatment, and Oh, by the way, we can’t get one of those standard treatments.’” (Lovelace Jr., 9/25)


Reuters:
Scynexis To Recall GSK-Partnered Antifungal On Cross Contamination Risk


Scynexis (SCYX.O) said on Monday it would voluntarily recall its antifungal pill, which it has licensed to GSK (GSK.L), due to risk of cross-contamination with a potential allergy-inducing compound, sending the drugmaker’s shares tumbling over 30%. The drugmaker said it became aware substances used to make drugs that contain beta-lactam are manufactured using equipment also used to make its treatment, called Brexafemme. (Mishra, 9/25)


Reuters:
Pakistan Probes Distributors Of Roche Cancer Drug After Patients Go Blind


Pakistan said on Monday it was investigating two local distributors of Swiss pharmaceutical company Roche’s (ROG.S) Avastin cancer drug after 12 diabetic patients injected with the drug went blind. The Drug Regulatory Authority of Pakistan (DRAP) said the health authorities in Punjab, the most populous province, had launched the investigation into local use of the drug Avastin, which is licensed for use in Pakistan. … On its website, Roche said Avastin was approved in more than 130 countries, including the United States, to treat several types of cancer. (Bukhari, 9/25)

Labor Conditions, Burnout Drive Health Care Workers To Picket Line

A multi-state strike is now planned by over 75,000 Kaiser Permanente workers for Oct. 4-7, unless a deal is struck. Nurses in St. Louis and dialysis workers in California are also participating in a short work stoppage. It’s part of an increasing trend as health care workers say the they are still experiencing work pressures caused by the covid pandemic.


California Healthline and KFF Health News:
Massive Kaiser Permanente Strike Looms As Talks Head To The Wire


Kaiser Permanente and union representatives pledged to continue negotiating a new contract up until the last minute as the threat of the nation’s latest large-scale strike looms next month. Unless a deal is struck, more than 75,000 health workers will walk out for three days from Oct. 4-7, disrupting care for KP patients in California, Colorado, Oregon, Virginia, Washington, and Washington, D.C. The unions represent a wide range of KP health workers, including lab technicians, phlebotomists, pharmacists, optometrists, social workers, orderlies, and support staff. (Wolfson, 9/25)


St. Louis Public Radio:
St. Louis Nurses Strike For 24 Hours Outside SLU Hospital 


Dozens of nurses on Monday formed a picket line outside SSM Health St. Louis University Hospital on South Grand Boulevard to call for better staffing, guaranteed breaks and more comprehensive sick leave policies. The workers represented by the National Nurses United union earlier this month voted for the strike — nearly three months after their contract expired in mid-June. The nurses say they voted to strike for 24 hours after SSM did not address their concerns about retention and workplace violence due to short staffing. (Fentem, 9/25)

In other news relating to health care personnel —


Axios:
Staffing Crunch Hit Federal Health Facilities


A tight labor market, comparatively poor pay, COVID-19 requirements and a lengthy hiring process contributed to staffing shortages and decreased access to care at federal health care facilities during the pandemic, a new report found. Why it matters: Officials must do more to ensure facilities are properly staffed during normal operations and strategically plan for future pandemics and other health emergencies, according to federal agency watchdogs on the Pandemic Response Accountability Committee. (Goldman, 9/26)


Stat:
Emergency Workers More Likely To Restrain Black Patients: Study


In the chaotic environment of an emergency room, hospital staffers sometimes face the question of whether to use physical restraints when a patient is experiencing a behavioral crisis. Using restraints is meant to be a last resort in the face of a patient’s agitation in order to keep health care workers and others around them safe. But restraints can also lead to severe adverse outcomes for patients, including physical and psychological trauma. (Nayak, 9/25)

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