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The Golden State’s gambit to bring insulin prices down will include a multi-million investment to manufacture the drug. The investment will be welcome news for both those seeking employment and those looking for better insulin prices. Stay tuned to the manufacturing report for updates on this story and others in the wider manufacturing world. |
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Tyler Patchen |
News Reporter, Endpoints News
@TPatchenendpts
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California Governor Gavin Newsom (AP Photo/Rich Pedroncelli, File) |
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by Tyler Patchen
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As the Senate debates capping out-of-pocket insulin costs at $35 per month, California is moving forward with its plans to take matters into its own hands. Gov. Gavin Newsom set aside $100 million in the state budget for the manufacture of its insulin, with the hopes of making it more affordable for residents of the state. According to the budget, the insulin that will eventually be developed and manufactured will be a low-cost biosimilar insulin product. Newsom recently highlighted that $50 million will go toward the development of low-cost insulin products, with an additional $50 million for a California-based manufacturing facility. The idea is to provide both high-paying jobs and a stronger supply chain for the drug. The effort is part of Newsom’s wider plan for the state to make more of its own prescription drugs. “Nothing epitomizes market failures, more than the cost of insulin. Many Americans experience out-of-pocket costs anywhere from $300 to $500 per month for this life-saving drug,” Newsom said in a press conference. “California is now taking matters into our own hands the budget I just signed sets aside $100 million so we can contract to make our own insulin at a cheaper price close to at cost and to make it available to all.” However, the state has not presented any specifics on the manufacturing location or when work will start. |
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Johnson Lau, Athenex CEO (AP Images) |
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by Tyler Patchen
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After a stock plunge in 2021 following a key FDA rejection, cancer biotech Athenex crashed into penny stock territory this year and is now looking to sell a piece of itself to make some cash. The company has agreed to sell off all its equity interests in its China subsidiaries, which are primarily engaged in API manufacturing, to TiHe Capital (Beijing). The estimated $19 million deal will see Athenex receive at least 70% of the proceeds at closing, and the proceeds will be used to pay down existing debt and for general operations, the company said. However, Athenex and TiHe also plan to enter into a long-term supply agreement for the manufacture and supply of certain APIs but were mum on the details. The deal is subject to customary closing conditions, including obtaining certain regulatory approvals in China. “Following the sale of our Dunkirk facility, as well as the sale of our U.S. and European tirbanibulin royalty and milestone interests , the Athenex team continues to execute on our strategy to monetize our non-core assets, bolster our balance sheet, extend our cash runway and focus on our potential best-in-class NKT cell therapy program,” said Athenex CEO Johnson Lau in a statement. This sell-off comes as the Buffalo, NY-based biotech has been facing several issues over the past few years. In 2019, the firm's API facility in Chongqing, China had voluntarily suspended production activities, which had come amidst other accidents at chemical plants earlier that year in certain provinces of China that led to industry-wide plant inspections focused on product safety. |
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by Tyler Patchen
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While the monkeypox virus continues to rage across the country, more vaccines are making their way to the US. According to a report from the AP, thousands more doses of the monkeypox and smallpox vaccine Jynneos, manufactured by Bavarian Nordic, are expected to soon be shipped to the US after the FDA said they had completed an inspection of a Denmark-based manufacturing plant. More than 1.1 million doses of the vaccine purchased by the US government are currently sitting in Bavarian Nordic’s facility. The company previously said that it needed authorization from an on-site FDA inspection before it could be shipped stateside. So far, Bavarian Nordic has shipped 300,000 vaccine doses that were made at a third-party facility that had previously been authorized by the FDA. The US regulator typically requires inspections of all vaccine plants to ensure there are no safety or sterility issues, prior to a vaccine to hit the market, although the Pfizer and Moderna Covid-19 vaccines were notable exceptions as the agency conducted no new inspections prior to their authorizations. Bavarian Nordic’s Jynneos has been well touted by several governments since the monkeypox outbreak and the company has secured several contracts including a contract with Canada worth $56 million as well as with Germany and several other European nations. | Discovery Life Science acquires cell provider | Alabama-based Discovery Life Science has netted the acquisition of California-based research cell provider AllCells. |
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Glenn Mattes, TFF Pharmaceuticals CEO |
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by Tyler Patchen
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Only months after Texas-based TFF Pharmaceuticals netted a partnership with Catalent, the company is expanding its R&D and manufacturing operations in the capital of the Lone Star State, through the lease of a new 3,500-square-foot facility. The new space will be centered on increasing TFF’s total lab space. The expansion adds a dedicated lab for the downstream processing of products created via its thin film freezing as the company is looking to increase its in-house research. The additional lab space will allow the company to house larger equipment to scale up its manufacturing abilities and produce supplies for preclinical studies. TFF plans to take its new space online by August. TFF also plans to expand its product development team in Austin, which will be based at the new facility but did not disclose the number of hands it wants to bring on. The lease arrangement was also used to finance the facility. TFF disclosed in an email to Endpoints News that the expansion was self-funded, but no hard figure was given. According to the company, the facility was previously used as a healthcare testing laboratory and the company has, over the past two to three months, made modifications to enable product development and testing of their technology. “The Austin facility will enable us to increase testing capacity so that we can run a larger number of feasibility studies, including a focus on biologics where demand has continued to grow. Additionally, as many of our partnered programs move to clinical evaluation, the ability to scale-up manufacturing in parallel becomes mission critical,” said John Koleng, TFF’s VP of product development and manufacturing. |
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Rendering of the mRNA competence center at the Wacker Biotech site in Halle (Credit: Wacker Chemie AG) |
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by Tyler Patchen
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As the mRNA field has become more popular over the past several years, thanks in large part to the development of certain wildly popular Covid-19 vaccines, such as those from Moderna and BioNTech, more companies are looking to sink funds to accommodate its production. German chemical company Wacker Chemie AG, which has been around since 1914, has been a mainstay in the production of silicone-based products and other medicinal chemicals, but now its biotech division is looking to sink nine figures into mRNA production. On Tuesday, the company announced it is investing over €100 million, or over $101 million, into the development of the company’s biotech site in Halle, Germany into a new center to manufacture mRNA active ingredients. The production capacity at the site will more than triple as part of the expansion. According to the design firm Exyte, which is the designer and builder of the project, the site will add a total of 7,400 square meters to the gross floor area and 1,600 square meters will serve as a clean room. Four new production lines are to be built, with part of the space being made available to the German government for a program to prepare for any future pandemics. “We are happy that our expertise in making mRNA vaccines will contribute to the fight against future pandemics. The expansion of our Halle site will create capacity to prepare for pandemics and beyond,” said Wacker CEO Christian Hartel. |
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Bob Kramer, Emergent BioSolutions CEO |
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by Tyler Patchen
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While Covid-19 and monkeypox currently dominate headlines and social health priorities, government officials aren’t forgetting about Ebola and its potential for serious outbreaks. Emergent BioSolution inked an agreement last week with Ridgeback Biotherapeutics in a collaboration to expand the availability of Ebola treatment Ebanga. Under the deal, Emergent will be responsible for the manufacturing, sale and distribution of Ebanga in the US and Canada. Ridgeback Bio for its part will serve as the global partner for the drug and ensure it remains available to patients in endemic countries free of charge through its compassionate use program. Financial details and timeline for the initiative were not disclosed. “This relationship with Ridgeback Bio builds on our strategic focus and deep expertise in developing and supplying medical countermeasures against serious health threats. Ebanga is crucial in the ongoing fight to contain Ebola and we are excited about the future of this collaboration to create a healthier, more secure world,” Emergent CEO Bob Kramer said in a press release. Ebanga is a monoclonal antibody single injection developed for the treatment of Ebola by Ridgeback under license from the NIAID. Ridgeback provided the funding and operational support for clinical testing, with additional funding under contracts with BARDA for late-stage manufacturing and regulatory activities. The drug was approved by the FDA in 2020 and was the second Ebola treatment to gain US approval. Regeneron’s antibody cocktail was first, getting an FDA nod in October 2020 and chosen by BARDA for the national stockpile in case of an outbreak. |
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John Rim, Samsung Biologics CEO |
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by Tyler Patchen
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As the biotech manufacturing arm of one of Korea’s largest conglomerates is aiming to rapidly expand its global presence after a large investment by its parent, Samsung Biologics is also keeping a close eye on environmental, social and governance (ESG) goals. Its second ESG report breaks down the company’s goals for renewable energy in future projects as well as a bigger commitment to reduce emissions. The report lays out progress in reducing both direct and indirect emissions and doubles down on its commitment to drop the total by 54% by 2026 compared to 2021. That comes on top of a 32% reduction year over year. Samsung Biologics also said it would cut "other" emissions such as indirect greenhouse gases from transportation and distribution by about 26% by 2026. The company is also actively working with suppliers to transition to net zero emissions as well as invest in renewable energy. CEO John Rim told Endpoints News in an email that along with the emissions drops, the big change since the last report is that the company is now participating in a series of climate change-related initiatives. That includes the company's involvement in the Sustainable Markets Initiative, which was launched by the royal family in the UK to reduce emissions in the supply chain. Samsung also plans to participate in a climate risk management modeling project by Financial Supervisory Service, called Frontier 1.5D, and the Carbon Disclosure Project where it currently holds a B rating. |
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Pramod Yadav, Jubilant Pharma Limited CEO |
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by Tyler Patchen
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Fresh off netting a contract from the US government for its facility in Washington, CDMO Jubilant HollisterStier is looking north of the border for its next move. The company, a subsidiary of Singapore-based Jubilant Pharma Limited, has secured a deal with the Government of Quebe to spend $77 million to expand the capacity at its facility in Montreal. Investissement Quebec granted a $19.2 million loan to help with the expansion efforts. According to Jubilant, the investment will seek to modernize and more than double the site's drug production capacity but did not specify by how much. Jubilant will also look to acquire new equipment and outfit the plant with a single-use sterile preparation room to maximize its filling process in the production of liquid sterile products. The facility also has an array of non-sterile manufacturing services producing ointments, creams, gels and other liquid products. CEO Pramod Yadav said in a statement, "Jubilant is excited to be chosen as a part of the eco-system being developed by Canada to make it self-dependent for its future needs of vaccines and treatments in case of a pandemic. This funding will enable our continued effort to expand our capabilities in Canada and create more jobs." In May, the company also entered into a cooperative agreement for $149.6 million with the Army Contracting Command, to enable Jubilant to double its injectable filling production capacity at its Spokane, WA manufacturing facility for a total cost of $193 million. That project is slated for completion in 2025. |
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by Tyler Patchen
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Several Indian drug manufacturers have been put under a microscope by the FDA, as major generics manufacturers have been hit in recent months by Form 483s. And now Dr. Reddy’s Laboratories is the latest to get the slap. According to the Indian business news site Business Standard, Dr. Reddy’s Laboratories was served a Form 483. The form highlighted two observations after inspecting its manufacturing facility located at Srikakulam, India, a city in the east. The regulatory filing noted that the facility in question is Dr. Reddy’s formulation facility dubbed FTO 11. However, the specifics of what was observed have not been released. The inspection itself was conducted from June 30 to July 7 of this year. Dr. Reddy’s Laboratories site in Srikakulam has not escaped the gaze of the FDA in the past. The site was hit with 483’s in 2014 and 2017, with the company receiving 14 prior Form 483s since 2017. The result of the 483 is not great for the investment line for Dr. Reddy’s as they have seen their stock price drop 14% since January. However, Dr. Reddy’s is not the only Indian company that is managing to rack up a high number of inspections and observations. Sun Pharma’s plant in Halol, India received several stark observations from the FDA including deficient procedures to prevent microbiological contamination of drugs, as well as deficient aseptic processing areas for monitoring environmental conditions and equipment and utensils not being cleaned or sanitized at appropriate intervals, among others. |
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by Tyler Patchen
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While the bear market still has its hold over the biotech sector, Greenwich LifeSciences is welcoming the latest news from the FDA. The biotech announced Tuesday that the FDA has removed the clinical hold on a Phase III trial for GLSI-100, an immunotherapy in HLA-A*02 positive and HER2/neu protein positive subjects who are at elevated risk for breast cancer recurrence. With the hold lifted, regulators are allowing the pivotal trial, dubbed Flamingo-01, to proceed. Investors jumped at the news, sending Greenwich shares GLSI up more than 50% in early Tuesday trading. The trial is for patients who have completed both neoadjuvant and postoperative adjuvant standard of care therapy. According to clinicaltrials.gov, 598 participants have taken part in Greenwich’s trials. The company said in a statement that the Phase III trial was placed on hold due to the manufacturing and pharmacy process, although no specifics were given. As part of the trial's resumption, Greenwich will incorporate additional testing of GP2 in the pharmacy process. According to Greenwich's first quarter report to the SEC, the company had completed the last steps of manufacturing GP2 and released three clinical lots of drug product believed to have met all release specifications. The biotech was awaiting FDA review of the manufacturing data. However, Greenwich said the FDA had previously asked the company informally to delay the Phase III trial until it had submitted updated manufacturing information, as that data package was incomplete with some lots still being tested for the first time. The FDA then imposed the hold to halt the trial's launch until Greenwich provided such information. |
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