Target $360
Wednesday, November 10, 2021
Seres, Bacthera to Collaborate for Commercial Manufacturing of SER-109 C. Difficile Treatment
Bacthera, a specialized contract development and manufacturing organization (CDMO), and Seres Therapeutics, a leading microbiome therapeutics company, announced today a collaboration to manufacture SER-109, Seres’ lead product candidate for recurrent Clostridioides difficile infection (rCDI). Under the terms of the agreement, Bacthera is establishing a dedicated facility for commercial manufacturing in its new Microbiome Center of Excellence, a manufacturing site dedicated to the production of LBPs located on Lonza’s Ibex® campus in Visp, Switzerland.
CDI, causing severe diarrhea and colitis, an inflammation of the colon, has been classified as one of the greatest microbial threats to human health by the Centers for Disease Control and Prevention (CDC). It is the leading cause of hospital-acquired infections in the United States and is responsible for 170,000 hospitalizations and the deaths of more than 20,000 Americans each year.1 SER-109 is a potentially first-in-class investigational microbiome-based therapeutic consisting of bacterial spores from healthy human donors. This consortium of human microbiota from the gastrointestinal tract is designed to prevent further recurrences of C. difficile infections.
RenovoRx Presents on Intra-Arterial Chemotherapy Treatment for Pancreatic Cancer
RenovoRx, Inc. (Nasdaq: RNXT), a biopharmaceutical company and innovator in targeted cancer therapy, today announced its novel therapy platform, RenovoTAMPTM (RenovoRx Trans-Arterial Micro-Perfusion), will be highlighted during a presentation by expert panelist, Dr. Ripal Gandhi, at the Miami Cancer Institute’s New Advances in the Management of Pancreatic Cancer CME course this evening.
Dr. Gandhi, a Principal Investigator in RenovoRx’s ongoing Phase 3 TIGeR-PaC study, and Professor of Interventional Radiology at the Miami Cancer Institute and Miami Cardiac and Vascular Institute, Florida International University Herbert Wertheim College of Medicine, will describe the results from initial clinical studies of RenovoTAMP used in combination with radiation therapy and its benefits when managing patients with stage 3 locally advanced pancreatic cancer (LAPC). He will also review the key stages of the TIGeR-PaC protocol which uses RenovoTAMP for the intra-arterial delivery of gemcitabine, an approved chemotherapeutic agent, to treat unresectable LAPC. To highlight a critical difference between intravenous (IV) and intra-arterial (IA) chemotherapy, Dr. Gandhi will present pharmacokinetic data, or data describing the drug absorption/distribution/metabolism/excretion of gemcitabine from five patients in the Phase 3 TIGeR-PaC study that received intra-arterial gemcitabine. The data demonstrates an approximately two-thirds reduction in systemic gemcitabine when compared to systemic levels in patients traditionally receiving IV infusion of gemcitabine.
“This innovative therapy platform is enabling the targeted treatment of inoperable LAPC with decreased side effects typical of systemic chemotherapy, while shifting the focus to what is most important to our patients: improving quality of life and allowing them to spend more time with their family and loved ones,” said Dr. Gandhi. “RenovoTAMP, when used in combination with radiation therapy, is designed to reduce arterial microvasculature, thereby minimizing leakage during drug delivery and enhancing drug delivery directly to the tumor.”
A copy and recording of Dr. Gandhi’s presentation, titled “Potential Future Innovative Strategy for Pancreatic Cancer: Intra-Arterial Chemotherapy,” will be available on RenovoRx’s website at https://renovorx.com.
Perrigo cuts guidance after Q3 report
Major Strategic Initiatives Completed During Q3:
- Closed sale of Rx business for $1.6B
- Announced Acquisition of HRA Pharma for €1.8B
- Settled €1.6B Irish Tax Assessment for Net Cash Outlay of €266M
- Awarded €355M From Belgium Arbitration Decision
Supply Chain Disruption and Higher Input Costs Negatively Impact Q3 Results
2021 Financial Guidance Lowered
U.S. & European Consumer Self-Care Demand Robust and Accelerating
https://finance.yahoo.com/news/perrigo-reports-third-quarter-2021-113000431.html
Roche exec: Alzheimer's drug price will be competitive
Roche Holding AG, still months away from seeking regulatory approval of its experimental Alzheimer’s drug, is already taking aim at rival Biogen Inc’s Aduhelm, saying that its medication would be priced competitively.
Bill Anderson, head of pharmaceuticals at Roche, did not provide pricing details for the company’s treatment for the lethal brain-wasting disease, but indicated in an interview that it could be priced as much as 30% below Aduhelm’s $56,000-a-year cost.
When it launched in June, Biogen’s drug became the first approved medication that targets one of the changes in the brain that occurs with Alzheimer’s. But Aduhelm sales have stalled as Medicare, the U.S. government healthcare program for people over age 65, evaluates coverage.
The delay has opened up opportunities for rivals such as Roche whose drugs are still many months away from U.S. Food and Drug Administration review and their approval is uncertain.
Anderson said Roche has priced new therapies in the United States “at or below the prices of things we replace ... even though we had superior results.”
Roche, Biogen and other drugmakers are due to present data this week at the annual Clinical Trials on Alzheimer’s Disease conference in Boston.
Roche’s Alzheimer’s candidate gantenerumab, like Aduhelm, is designed to remove amyloid plaques from the brains of people diagnosed with the disease. Roche has said it will wait for pivotal trial results, due in the second half of 2022, before seeking regulatory review.
Anderson told Reuters that Roche aims to show “unequivocal data on efficacy.”
The FDA approved Biogen’s drug based on evidence that it reduces amyloid brain plaques, a likely contributor to Alzheimer’s, rather than proof that it slows the disease’s progression.
Eli Lilly & Co has begun a rolling FDA application for its own experimental Alzheimer’s drug based on evidence of its plaque-removing ability. Lilly’s drug could get U.S. approval by the second half of next year.
Medicare expects to issue a final decision in April on its reimbursement policy, which will apply to all plaque-reducing agents.
Biogen posted third-quarter Aduhelm sales of just $300,000, far below the $11 million Wall Street had expected. Some neurology centers using the drug have said the company is providing Aduhelm, given as a monthly infusion, free of charge while the insurance claims process is worked out.
Businesses left in limbo on COVID-19 mandate
Businesses are in limbo after a federal court halted the Biden administration’s vaccine-or-test mandate for private employers.
Employers are preparing to enforce the Occupational Safety and Health Administration’s (OSHA) rule, which would require businesses with 100 or more employees to mandate COVID-19 vaccinations or weekly testing by Jan. 4.
But it’s now unclear whether the requirement will survive legal challenges after the 5th U.S. Circuit Court of Appeals temporarily blocked the rule over the weekend, creating confusion among companies on how to move forward. Labor lawyers are urging businesses to continue preparing for key OSHA deadlines, given that the court’s stay, for now, is only temporary.
“I think it’s prudent for employers to proceed with planning assuming that the OSHA rule, at least in some form or fashion, will be implemented pending final resolution of the various court cases,” said Michelle Strowhiro, a lawyer at McDermott Will & Emery who advises businesses on COVID-19 employment issues.
While the OSHA rule requires businesses to mandate weekly testing for unvaccinated employees by January, the most important deadline is coming up soon. By Dec. 5, employers must collect employees’ proof of vaccination and provide paid leave for those getting the shot, while unvaccinated employees must begin wearing a mask.
The risks are high for businesses banking on the rule being overturned. Employers that don’t comply face fines of up to $136,532 for willful violations.
“Employers should be keeping one eye on the courts and one eye on taking the steps necessary to comply with the regulation by the time it comes into effect in early December so that they’re not caught flat-footed,” said Evandro Gigante, an employment attorney at Proskauer Rose LLP.
Large companies that don’t already track their employees’ vaccination status are scrambling to adopt systems to verify that information ahead of the December deadline. They’re also crafting rules that lay out religious and disability accommodations and the penalties for employees who don’t comply with the OSHA requirement.
“Most employers are of the view that they should plan for it to come into effect and not necessarily assume that it’s going to be overturned, and if and when that happens, take steps to walk back whatever steps they’ve taken to implement the new policy,” Gigante said.
The OSHA rule has already drawn a flurry of lawsuits from GOP-led states and conservative interest groups. Following a challenge from Texas, Louisiana, Mississippi, Utah and South Carolina, the 5th Circuit temporarily halted the rule Saturday, citing “grave statutory and constitutional issues.”
The Justice Department on Monday urged the panel to reverse the stay, arguing that the court had no reason to block the OSHA rule now as it doesn’t go into effect until December. The Justice Department said that halting the rule “would likely cost dozens or even hundreds of lives per day.”
“With the reopening of workplaces and the emergence of the highly transmissible Delta variant, the threat to workers is ongoing and overwhelming,” the Justice Department told the court.
The OSHA rule has been challenged in several different circuit courts, and the cases will likely be combined into one and sent to a federal appeals court as soon as next week. Experts say the lottery will probably send the case to a less conservative court than the 5th Circuit, which previously allowed Texas’s controversial six-week abortion ban to remain in effect.
Whichever side loses the case is expected to appeal to the Supreme Court, which has a 6-3 conservative majority. Labor lawyers largely believe that the OSHA standard is constitutional, and they note that it is less strict than other federal vaccine mandates for health care workers and federal contractors. However, it’s still unclear whether the rule would survive the high court.
In the meantime, the Biden administration is urging large employers to move forward with workplace vaccine requirements as it fights to protect its rule in court.
“We think people should not wait,” Karine Jean-Pierre, White House deputy press secretary, told reporters Monday. “We say, do not wait to take actions that will keep your workplace safe. It is important and critical to do and waiting to get more people vaccinated will lead to more outbreaks and sickness.”
Conservative groups challenging the OSHA rule jumped on the White House statement, arguing that the Biden administration sensed defeat.
“By encouraging businesses to continue implementing vaccine rules for their employees, the Biden administration must be worried about losing and is trying to get as many employers to comply before its ultimate demise,” Alfredo Ortiz, president and CEO of the conservative Job Creators Network, said in a statement.
Private vaccine mandates have steadily grown more popular throughout the pandemic. Several companies, including United Airlines and Tyson Foods, have already enacted their own vaccine requirements that are far stricter than the minimum OSHA standard.
An October survey from consulting firm Mercer found that 34 percent of employers — made up mostly by businesses with 100 or more employees — currently have some form of vaccine mandate in place.
Those mandates are least popular among businesses with a high percentage of blue-collar workers, which fear they could lose unvaccinated employees amid a tight labor market. The Mercer poll found that just 2 percent of retailers and 4 percent of manufacturing firms require all employees to get vaccinated.
The pandemic continues to kill more than 1,000 people in the U.S. every day, largely among the unvaccinated. The Biden administration says that the OSHA rule alone will save thousands of lives and prevent more than 250,000 hospitalizations during its first six months.
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