Latest news with #Cosette
Business Wire
30-06-2025
- Business
- Business Wire
Cosette Pharmaceuticals Appoints Jeff Neubig as Vice President, Quality and Regulatory Affairs
BRIDGEWATER, N.J.--(BUSINESS WIRE)--Cosette Pharmaceuticals, Inc., a U.S.-based, fully integrated, pharmaceutical company, announced today that it has appointed Jeff Neubig as Vice President, Quality and Regulatory Affairs. In this critical role, Jeff will lead Cosette's best-in-class quality and regulatory affairs organizations, maintaining the company's rigorous quality standards and further establishing Cosette's strong position as a respected and reliable supplier of high-quality medicines. 'We are thrilled to add an experienced quality and regulatory leader like Jeff to Cosette, further establishing our unwavering commitment to delivering high quality, reliable products that has resulted in 24 new product launches over the last three years with zero major quality observations,' said Apurva Saraf, President and CEO, Cosette Pharmaceuticals. 'As we scale our business exponentially, Jeff's proven track record in quality leadership and regulatory strategy will be instrumental in delivering affordable and accessible therapies with speed and precision.' Prior to joining Cosette, Jeff served as Vice President of Quality and Regulatory Affairs, North America at LTS Lohmann Therapy Systems, where he successfully oversaw multiple regulatory inspections with zero observations, provided regulatory guidance and wrote filings for IND, NDA and ANDA products, and led tech transfer and validation teams, among other achievements. 'I'm excited to be joining Cosette at this time of strong momentum and progress to help bring critical therapies to patients,' said Jeff Neubig, Vice President, Quality and Regulatory Affairs, Cosette Pharmaceuticals. 'Cosette is widely known and respected for being a high-quality, reliable supplier of medicines. I'm thrilled to help advance that important work and lay the foundation for continued long-term growth.' Jeff brings over 35 years of experience in the pharmaceutical industry to Cosette, including over 25 years leading quality assurance, quality control and regulatory affairs teams, working with products from pre-clinical development all the way through commercial operations. He has worked in companies specializing in transdermal patches, oral thin films, liquid formulations, sterile injectables and solid oral dosage forms. Jeff earned a Ph.D. in Evolution, Ecology and Organismal Biology from The Ohio State University, an MS in Biology from Montclair State University, and a Bachelor's degree in Biology from Mount Saint Mary's College. About Cosette Pharmaceuticals Cosette Pharmaceuticals, Inc. is a U.S.-based, fully integrated pharmaceutical company with a fast-growing portfolio of products in women's health and dermatology. Cosette has a long history in quality manufacturing of complex dosage forms including topical creams, ointments, oral liquids/solutions and suppositories. Cosette has corporate and manufacturing facilities in New Jersey and North Carolina and is supported by 350+ dedicated team members across all functional areas. Cosette is backed by Avista Healthcare Partners, a healthcare focused private equity firm, and funds managed by Hamilton Lane, a private markets investment management firm (Nasdaq: HLNE). For more information, please visit or follow Cosette on LinkedIn.
News.com.au
18-06-2025
- Business
- News.com.au
Health Check: Mayne Pharma shareholders back $600m ‘phantom' takeover offer
Mayne investors today strongly endorsed Cosette's non-existent takeover offer Audeara's improving sales are loud and clear We ferret around for all the latest clinical trial news Mayne Pharma (ASX:MYX) shareholders have overwhelmingly approved the company's $600 million takeover scheme of arrangement, even though suitor Cosette has terminated the deal. At the Melbourne meeting, the company reported 699 proxy votes in favour of 98.57%, compared with four 'nays' accounting for 0.95%. Open proxies accounted for a further 0.47% or so. The deal is a phantom one, in the sense that Cosette pulled out on the grounds that adverse material events had occurred. Such a withdrawal is allowable under the scheme implementation deed (SID). In a cross claim, Cosette alleges Mayne engaged in misleading or deceptive conduct. Mayne disputes these allegations and says the SID – now glowingly endorsed by investors – remains valid. The company has filed NSW Supreme Court proceedings to seek such a ruling. Chairman Frank Condella told holders the SID was subject to a favorable court adjudication, 'in the absence of any other agreement being able to be reached with Cosette in relation to the dispute.' He warned that if Mayne's legal quest fails, the company may be subject to 'financial detriment, including damages claims and/or costs orders and the payment of a break fee to Cosette ." That said, Mayne directors believe that it's in the shareholders' best interest to pursue litigation. Hear! Hear! Audeara in bullish trading update The maker of own-brand and white label devices to assist hearing, Audeara (ASX:AUA) says it is poised for a record year on the back of sales orders from two key clients. The company reported unaudited revenue for the year to June (eleven months) of $3.64 million, up 14% on the previous year and 25% higher than in the 2022-23 year. Audeara's fortunes have been underpinned by the launch of Taiwan hearing device leader Clinico's co-branded sound buds, which imbed Audeara's 'secret sauce' tech. This tie up resulted in an initial $570,000 order. The company also received a follow-up order of $917,000 from 400-year-old musical instrument maker Avedis Zildjian. Audeara also grew Australian wholesale sales by 16%, to $1.67 million. Management expects additional growth in coming weeks, including sales to wholesalers, retailers and resellers. We're 'earing different things about Cochlear Still on hearing devices, broking analysts have offered different takes on Cochlear's (ASX:COH) prospects after the company last Thursday downgraded full-year earnings expectations by 2-5%. And that's okay – it's a democracy after all. The company said its moderated outlook resulted from slowing growth for both cochlear implants and sound processors in its developed markets. Investors ponder to what degree Cochlear's new off-the-ear (OTE) Kanso 3 sound processor – and the next-gen implant Nucleus Nexa – will rev up sales. UBS has upped its call on the stock from neutral to a buy, with a new price target of $325 compared with $285 previously. The company believes Cochlear's new implants can boost its compound annual revenue growth by 10% over the next three year. Over this period, the firm expects Nucleus Nexa to increase Cochlear's global implant share by 3%, to 63%. Cochlear this month is launching the device in Europe and the Asia Pacific. Maintaining a 'hold', Morgans lowers its 'target price' from $286.24 to $281.36. 'While new systems tend to precede re-rates, we remain cautious,' the firm says. Morgans notes Nucleus Nexa 'appears more about refining the user experience as opposed to offering technological advancements as seen with prior implant iterations.' Sounds like the Iphone phenomenon, in that the 'wow factor' is dulled with every new release. Argenica pursues brain damage study Today's clinical trial updates come courtesy of rats, mice and ferrets and we thank these rodents and weasels for their sacrifice. In the case of Argenica Therapeutics (ASX:AGN), the brain and neurogenerative injuries specialist will forge head with a trial of its drug candidate ARG-007. This is for the hard-to-treat traumatic brain injury (TBI). This go-ahead follows a second preclinical study in a large cohort ferret. This showed ARG-007 resulted in 'significant long-lasting reduction in brain cell damage and inflammation following injury.' This 14-day study extended an initial three-day pilot effort. Aregenica says the ferret model 'closely resembles the gross anatomy of the human brain'. Combined with previous rat studies and the pilot ferret trial, this provides a 'robust preclinical data package'. TBI affects 69 million people globally annually, with no approved therapies. The University of Adelaide carried out the study, partly funded by a federal grant. The results should soothe investor disappointment over last week's setback, when the FDA placed a 'clinical hold' on Argenica's request to carry out a US ischaemic stroke trial. However, the company says its local phase II trial, now at dosing stage, is unaffected. Inoviq's (Exo) Ace trial news Inoviq (ASX:IIQ) reports that in vitro lab work has shown that one of its drug candidates killed 88% of aggressive triple negative breast cancer and lung cancer cells. The treatment deploys exosomes: tiny particles that deliver targeted therapies. The story gets complex because Inoviq uses engineered immune cell particles called CAR-NK-EVs, overlaid with its special process called Exo-Ace. The short explanation is the efforts could lead to an 'off the shelf' therapy that is faster, safer and more effective than traditional cell therapies (such as burgeoning CAR-T treatments that involve tricking up the T cells). Inoviq now will test the treatment in mice. It's very early days, but Inoviq shares this morning surged as much as 21%. Lumos enrolls its 500th patient Meanwhile, Lumos Diagnostics (ASX:LDX) has enrolled its 500 th patient in a study to clear its Febridx assay for US sale. A point-of-care test, Febridx rapidly distinguishes between bacterial and viral infections. The tricky bit is enrolling enough bacteria-positive patients and to date the company has corralled 78 of the requisite 120. By reaching 500 patients, Lumos has pocketed a US$298,457 milestone payment from its partner, the Biomedical Advanced Research and Development Authority (BARDA). BARDA hands over another US$746,143 when the trial enrols the last patients. Lumos doesn't specific a number, but expects the process to complete by the end of 2025. Lumos is seeking so-called CLIA (Clinical Laboratory Improvements Amendment) waiver. This enables simple tests to be used by less trained staff such as nurses and receptionists.
AU Financial Review
09-06-2025
- Business
- AU Financial Review
Proxy advisers support Mayne Pharma deal as suitor tries to exit
A legal dispute between Mayne Pharma and private equity suitor Cosette, which has terminated its $672 million takeover offer for the Adelaide-based target, may drag on in the courts for years unless the bidding parties settle their dispute ahead of a shareholder vote on the deal in two weeks. Shareholders and sources close to the transaction, who were not authorised to speak publicly, said there was no legal precedent in Australia for Cosette's termination based on its claim that there has been a material adverse change in Mayne Pharma's financial position.
AU Financial Review
04-06-2025
- Business
- AU Financial Review
Cosette terminates Mayne Pharma deal as legal challenge looms
US pharmaceutical giant Cosette has terminated its $672 million takeover bid for Adelaide-based drug company Mayne Pharma, but the target company says it will challenge the move in the courts. Mayne Pharma shares fell as much as 7 per cent on Wednesday after it told investors it had received notice from private equity-backed Cosette that it would terminate the $7.40 per share offer, setting the stage for a potential legal battle.
AU Financial Review
21-05-2025
- Business
- AU Financial Review
Mayne Pharma shares crash after suitor Cosette threatens to walk
US pharmaceutical giant Cosette has threatened to abandon its $672 million takeover bid for Adelaide-based drug company Mayne Pharma after the target issued weaker-than-expected earnings guidance and disclosed a possible US regulatory issue with one of its key products. Mayne shares plunged more than 30 per cent on Wednesday after it said private equity-backed Cosette was reviewing the deal because it thought there had been a 'material adverse change' in the company's financial performance since it made its offer in February.
