PharmaFocus Today – Page 313 – media

Apellis Eye Injection Treatment Flagged for Safety Issues

Pictured: Healthcare worker checking the eye of an elderly woman patient/iStock, peakSTOCK Apellis’ recently approved eye injection Syfovre (pegcetacoplan injection) has been linked to several cases of retinal vasculitis, a rare complication involving eye inflammation, according to the American Society of Retina Specialists’ Research and Safety in Therapeutics Committee, as reported by several media outlets. In a press statement posted Saturday, Apellis confirmed seven retinal vasculitis cases, two of which arose in April 2023 following Syfovre injections, while two others were detected in May and three in June. The company has also received a report of one other retinal vasculitis event, but has yet to confirm this. Apellis has carried out a comprehensive investigation of these complications, including a review of Phase III safety data from Syfovre’s development program, as well as of its manufacturing process. However, “there is no indication that the drug product or manufacturing issues contributed to these events,” the ...
- Source: drugdu
- 120
- August 2, 2023
Sumitomo, Otsuka’s Schizophrenia Candidate Fails Phase III Trials

Pictured: Woman in mental anguish/iStock, Marina Demeshko Sumitomo Pharma and Otsuka Pharmaceutical announced Monday that two Phase III studies of ulotaront failed to meet primary endpoints for acutely psychotic adults living with schizophrenia. The studies, DIAMOND 1 and DIAMOND 2, pitted the trace amine-associated receptor 1 (TAAR1) agonist against a placebo. After six weeks, the studies showed improvement on the Positive and Negative Syndrome Scale (PANSS), but results were not superior to placebo. A “large placebo effect” was present in both studies “which may have masked the molecule’s therapeutic effect,” according to the press release. While placebo responses are frequently higher in psychiatric studies, Sumitomo CEO Hiroshi Nomura pointed to COVID-19 as a potential culprit for the high placebo effect as the studies were conducted throughout the pandemic. The molecule was part of a four-compound deal forged between Otsuka and Sunovion, a subsidiary of Sumitomo, nearly two years ago. The former made an upfront payment of ...
- Source: drugdu
- 109
- August 2, 2023
FDA approves second over-the-counter naloxone nasal spray for opioid overdose

The US Food and Drug Administration (FDA) has approved the over-the-counter (OTC), non-prescription use of Harm Reduction Therapeutics’s RiVive, a 3mg naloxone hydrochloride nasal spray, for the emergency treatment of known or suspected opioid overdose. The FDA’s decision means that RiVive stands as the second non-prescription, OTC naloxone nasal spray product that the agency has approved. FDA commissioner, Robert Califf, said: “We know naloxone is a powerful tool to help quickly reverse the effects of opioids during an overdose. “Ensuring naloxone is widely available, especially as an approved OTC product, makes a critical tool available to help protect public health.” Prescription opioids, such as morphine, codeine and fentanyl, are used as treatments to relax the body and relieve pain. However, misuse of opioids can lead to several harmful effects, including slowed breathing, and hypoxia, which can ultimately lead to death. In the US, drug ...
- Source: drugdu
- 121
- August 2, 2023
Biogen, amid layoffs, ponies up $7.3B for rare disease specialist Reata and potential blockbuster Skyclarys

On Monday during a quarterly earnings call, when Biogen CEO Chris Viehbacher was asked about the company’s potential to execute M&A, he randomly offered “we’ve got, I think, about $7.3 billion in cash?” Four days later, Biogen has revealed a proposal to acquire Reata Pharmaceuticals. The Massachusetts biotech will pay $172.50 per share for the Plano, Texas-based rare disease specialist in a deal that comes to—you guessed it—$7.3 billion. With the purchase—which is a 59% markup on Reata’s shares from close of the market on Thursday—Biogen gains Skyclarys, the first treatment for the rare, inherited neurologic disorder Friedreich’s ataxia. It was approved by the FDA in February of this year and carries sales potential of $1.5 billion in 2030, according to analysts. On a conference call Friday to bookend the busy week, Viehbacher called Biogen “the natural owner for Skyclarys.” When the deal is done, Biogen will be able to ...
- Source: drugdu
- 141
- August 1, 2023
UKHSA data reveals a 45% decline in hepatitis C prevalence in England

The UK Health Security Agency (UKHSA) has published new data showing that there were an estimated 70,649 people living in England with hepatitis C in 2022, marking a 45% decrease from the number recorded in 2015. Since 2015, NHS England has treated over 80,000 people for the infection as part of its national elimination programme. Of those treated, more than 80% were from the most deprived areas in England, which the UKHSA says highlights “the role of eliminating hepatitis C as a key driver of reducing health inequalities”. Hepatitis C is a blood-borne virus that can cause life-threatening liver disease, including cancer. However, those infected often have no symptoms until years later when their liver has already been badly damaged. Spread through blood-to-blood contact, the virus is commonly contracted through sharing needles contaminated with the infection, but it can also be contracted through the sharing of razors or toothbrushes. Dr ...
- Source: drugdu
- 142
- August 1, 2023
Inflationary pressure causes drop-off in contract manufacturing M&A

AGlobalData analysis found that the total number of deals involving contract manufacturing organisations (CMO) peaked in 2021, but has declined considerably since then. In GlobalData’s “M&A in the Pharmaceutical Contract Manufacturing Industry” webinar, PharmSource editor Fiona Barry highlighted a drop-off in the volume of contract manufacturing mergers and acquisitions (M&As) in 2023 so far but remained optimistic that more activity would happen in the near future. A GlobalData analysis found that from 2021 to 2022, active pharmaceutical ingredient (API) manufacturers made up 45% of acquisition targets, involving both small molecule and biologic. In the last five years, Thermo Fisher Scientific’s $20.9bn acquisition of pharmaceutical clinical research organisation PPD ranked the highest in value. Barry also identified Cambrex Corp, Catalent, Charles River Laboratories and Recipharm, as the most active CMO acquirers. However, Barry reported that since late 2022, M&As in pharmaceutical manufacturing have steadily dropped off. “The amount we saw was ...
- Source: drugdu
- 110
- August 1, 2023
NS Pharma scores breakthrough therapy status for DMD therapy

The US Food and Drug Administration (FDA) has granted NS Pharma’s NS-089/NCNP-02 breakthrough therapy designation in a move that will help ramp up the future treatment options for Duchenne Muscular Dystrophy (DMD). The news follows another recent FDA win for NS Pharma, which is owned by Japanese pharmaceutical company Nippon Shinyaku, after its therapy was awarded a rare paediatric disease (RPD) designation earlier in July. A first-in-human clinical trial (NCT04129294) in six Japanese patients with DMD amenable to exon 44 skipping showed that the therapy increased dystrophin protein expression, and improved the motor function of patients as measured by The North Star Ambulatory Assessment. NS-089/NCNP-02 is an antisense nucleotide that helps cells skip over a particular exon. In the case of DMD patients, this is the mutated – and therefore dysfunctional – exon 44 in the DMD gene. Nippon Shinyaku discovered NS-089/NCNP-02 in a joint research project with the National ...
- Source: drugdu
- 217
- August 1, 2023
Merck’s Pneumococcal Shot Claims Back-to-Back Phase III Wins

By Tristan Manalac Pictured: Merck sign at its office in California/iStock, hapabapa Merck’s investigational pneumococcal vaccine V116 aced two Phase III trials, eliciting strong immune responses in both the Phase III STRIDE-3 and STRIDE-6 trials, the company announced Thursday. Without providing specific data, the drugmaker said that in STRIDE-3, V116 significantly outperformed the standard 20-valent pneumococcal conjugate vaccine at eliciting an immune response in adults who had not been immunized before. Meanwhile, STRIDE-6 showed that Merck’s investigational shot could prime immunity against all 21 targeted pneumococcal serotypes in adults aged 50 years and above who had been vaccinated at least a year prior. Both STRIDE-3 and STRIDE-6 also demonstrated that V116’s safety profile was comparable to the standard vaccine comparator used in these studies. “Despite the availability of current pneumococcal conjugate vaccines, many adults remain vulnerable to pneumococcal disease, especially those who are older,” Merck Chief Medical Officer Eliav Barr ...
- Source: drugdu
- 132
- August 1, 2023
Biogen Boosts Neuro Pipeline with $7.3B Reata Buy Amid Layoffs

Published: Jul 28, 2023 By Tristan Manalac Pictured: Biogen sign/The Boston Globe via Getty, John Tlumacki Biogen is dropping $7.3 billion in cash to acquire Texas-based Reata Pharmaceuticals aimed at bolstering its neurological and rare disease businesses, the companies announced Friday. Reata, whose shares soared 51% in premarket trading following the buyout news, recently won the FDA’s approval for Skyclarys (omaveloxolone), the first and so far only authorized treatment for Friedrich’s ataxia in the U.S. Reata is currently working on launching Skyclarys, which it will price at $370,000 per year. Under the terms of the agreement, Biogen will pay a per-share price of $172.50, which represents an approximately 58% premium to Reata’s closing price Friday. Biogen will make the payment in cash, supplemented by the issuance of term debt. The companies expect to close the deal in the fourth quarter of 2023, though it must first pass the heightened scrutiny ...
- Source: drugdu
- 106
- August 1, 2023
FDA Adopts New Sterilization Standard to Support Switch From Ethylene Oxide

Dive Brief The U.S. Food and Drug Administration has adopted an international sterilization standard to give medical device manufacturers another alternative to ethylene oxide (EtO). Manufacturers can now make declarations of conformity to the International Organization for Standardization’s recommendations on low-temperature vaporized hydrogen peroxide in submissions to the FDA. The FDA framed the addition of the ISO test to its Recognized Consensus Standards database as a response to pressure to reduce EtO use and the need to support supply chain resiliency. Dive Insight In April, the U.S. Environmental Protection Agency proposed limiting EtO emissions from sterilization facilities by 80% to minimize the risk of people developing cancer from exposure to the gas. AdvaMed has warned the limit could halve capacity at commercial sterilizing plants, and the FDA has cautioned that there is a lack of viable alternatives to EtO for many devices. The ...
- Source: drugdu
- 158
- July 28, 2023

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