Latest news with #JonathanGardner
Scoop
30-05-2025
- Entertainment
- Scoop
FANGZ - Announce Debut Album 'Shui' And National Tour, Reveal Blistering Single 'Anne Marie'
Eora/Sydney punk rockers FANGZ have announced their debut album ' Shui ', out Friday, July 4 via Impressed Recordings, alongside their biggest national headline tour yet. The news lands with their explosive new single ' Anne Marie ', produced by (LOSER) and mixed by Jonathan Gardner (Front End Loader, Grinspoon). 'Anne-Marie' unfurls with razor-sharp punk riffage, pounding rhythms, and Josh Cottreau 's searing belts, setting the tone for the track's unrelenting ferocity. Chant-along choruses erupt into an explosive bridge, unleashing a tidal wave of distorted guitars, double-timed drums and an exuberant solo cranking it up to eleven. Josh Cottreau touches on the meaning of the track: "'Anne Marie' is a heartfelt tribute to my sister, Leigh-Anne Marie — a constant source of strength, support, and unconditional love. The song reflects on moments of struggle, gratitude, and personal growth, honouring the one person who never gave up, even when times were hardest. It's a message of appreciation for her unwavering belief and a reminder to keep going and never stop doing what you love." FANGZ's latest national headline tour includes stops in Meanjin/Brisbane, Tarndayna/Adelaide, Boorloo/Perth, Naarm/Melbourne, Eora/Sydney, Ngunnawal/Canberra, Dharawal/Wollongong, Mulubinba/Newcastle, Yugambeh/Gold Coast and Gubbi Gubbi/Caloundra; tickets are available via This follows on from a busy 2025 launching the Melbourne and Brisbane contingents of FANGZstock and packing out the global premiere of ' Shui', presented by Great Southern Nights, at Trocadero Room, Eora / Sydney. The band have traversed the country multiple times, selling out headline shows, performing at festivals and sharing stages with the likes of FIDLAR (USA), Pennywise (USA), The Bronx (USA), Cancer Bats (CAN), RedHook, Comeback Kid (CAN) and He Is Legend (USA). Last year, FANGZ completed an East Coast tour in 24 hours, an annually curated festival 'FANGZstock', launched their own hot sauce ' Fang us Some Sauce ', and hold the Guinness world record for the most hard-boiled eggs eaten in one sitting by front man Josh Cottreau (143 eggs in three minutes and ten seconds). Since their 2019 inception, FANGZ have released three EP's ' For Nothing ' (2019), ' But No Thanks ' (2020), ' Falling Is Pretty Normal ' (2022), and a slew of singles, which received strong support from the likes of triple j, triple j Unearthed, Triple M, Spotify, Apple Music, Amazon Music, Metal Hammer (UK), Loudwire (USA), Classic Rock (UK), Metal Injection (USA), Louder Sound (UK), NME, Rolling Stone Magazine, The Guardian, and many more. Coming into 2025, the group has released singles ' Wasting Time ', ' Nothing To Lose ', ' Same Old Story ' and ' Wide Awake ' from their forthcoming debut album. The releases were warmly embraced by Spotify, Apple Music, triple j and numerous community radio stations, and blogs.
Yahoo
25-04-2025
- Business
- Yahoo
Halozyme sues Merck; FDA blames cuts for Vanda delay
This story was originally published on BioPharma Dive. To receive daily news and insights, subscribe to our free daily BioPharma Dive newsletter. Today, a brief rundown of news involving Merck and Vanda Pharmaceuticals, as well as updates from Sanofi and Novo Holdings that you may have missed. Halozyme Therapeutics has sued Merck & Co., alleging that the pharmaceutical company is infringing on multiple patents in developing a subcutaneous form of the cancer immunotherapy Keytruda. Halozyme has a drug delivery technology that can turn intravenously infused medicines into under-the-skin injections. The company licensed it to several drugmakers, among them Bristol Myers Squibb and Roche, which have used the technology to make subcutaneous versions of their own cancer immunotherapies. Halozyme expected Merck to do the same, but claimed the company instead used its technology to develop subcutaneous Keytruda 'without Halozyme's permission.' The Food and Drug Administration could approve the drug by Sept. 23. Halozyme is seeking damages and injunctive relief. — Jonathan Gardner Recent mass job cuts have impacted the FDA's ability to respond to Vanda Pharmaceuticals' challenge to a drug rejection the agency issued last year. Vanda previously claimed the FDA 'disregarded the evidence' from two placebo-controlled trials in turning back its gastroparesis drug. The company then challenged the ruling and accepted the agency's offer of an opportunity for a hearing. However, in a federal court filing, the FDA said layoffs are 'partially' to blame for that hearing not yet being recommended to commissioner Martin Makary, according to Vanda. The company called on Makary to step in and 'restore adherence to the law.' — Ben Fidler Sanofi revealed Thursday that a closely watched immune drug prospect failed a Phase 2 study in psoriasis. Called balinatunfib, the drug is a pill with the same target as popular injectable medicines like Humira. But while balinatunfib appeared as effective in testing as other oral psoriasis medicines, it missed its main objective because of the study's 'limited' nature. The company may explore its use in drug combinations and 'internal assessments and external discussions are ongoing,' Sanofi said. — Ben Fidler In a bid to bolster life sciences startups in the Nordic region, Novo Holdings and the Export and Investment Fund of Denmark are investing 48 million euros, or about $54.5 million, in the Swedish venture fund HealthCap IX. The new investment will enable HealthCap to 'establish a presence' at the BioInnovation Institute in Copenhagen, according to a Thursday statement. HealthCap supports early-stage companies emerging from academia and corporate research, and has invested in more than 130 companies its founding in 1996. — Gwendolyn Wu Avidicure, a new biotechnology startup working on antibody drugs, announced Thursday it raised $50 million in seed financing. The funding, led by EQT Life Sciences and involving five other firms, will help Avidicure advance a group of multifunctional antibodies it's developing for cancer. Avidicure claimed these therapies, which it calls 'AVC-boosters,' have properties that could make them superior to T cell engagers, checkpoint inhibitors and other popular cancer antibody drugs. Its top prospect is aimed at TROP2, a well-known lung cancer target. — Gwendolyn Wu
Yahoo
19-04-2025
- Business
- Yahoo
GSK prepares to relaunch Blenrep; Activists challenge another ‘zombie' biotech
This story was originally published on BioPharma Dive. To receive daily news and insights, subscribe to our free daily BioPharma Dive newsletter. Today, a brief rundown of news involving GSK and Bristol Myers Squibb, as well as updates from Elevation Oncology, Bayer and Airna that you may have missed. GSK's Blenrep has been approved in the U.K. to treat people whose multiple myeloma has progressed after one line of therapy, the company said Thursday. The clearance is Blenrep's first since it was withdrawn from the market three years ago following the failure of a confirmatory trial, and comes after the company succeeded in additional studies that have since positioned it for a relaunch. The Food and Drug Administration is set to decide on a new approval in the U.S. by July 23. — Jonathan Gardner Investment firm BML Capital Management has called for cancer drug developer Elevation Oncology to liquidate and return all of its cash to shareholders, according to a regulatory filing. Elevation dropped its lead drug, laid off a majority of its staff, and began a strategic review after reporting disappointing study data last month. That process often ends in a 'reverse merger' with a privately held company that then continues on in the public markets. However, BML, which owns 9.9% of Elevation stock, argued in a letter to management that winding down is the company's 'best course of action' given the state of the equity markets and the 'abysmal performance' of many recent reverse mergers. Multiple other struggling biotechs, including fellow cancer drug developer , have recently faced activist pressure as well. — Ben Fidler The FDA updated the prescribing information for Bristol Myers Squibb's hypertrophic cardiomyopathy drug Camzyos to ease risk monitoring requirements and lower the number of therapies it's contraindicated with, the company said Thursday. The updated prescribing information lowers the frequency of echocardiogram monitoring for some patients and removes two kinds of inhibitor drugs as contraindicated therapies. The move suggests 'greater comfort' with so-called cardiac myosin inhibitors like Camzyos and should help 'build out the still nascent' market for them, wrote Stifel analyst James Condulis. Camzyos generated $602 million in sales last year, and could soon face competition from Cytokinetics' aficamten, which is currently being reviewed by U.S. regulators. — Ben Fidler Ligand Pharmaceuticals and Channel Therapeutics will combine a trio of subsidiaries in a deal that will create a new company, Pelthos Therapeutics, focused on selling an already-approved prescription gel for molluscum infections. Pelthos will also own a portfolio of pain drugs aimed at Nav1.7, a target of interest to other developers as well, including Vertex Pharmaceuticals and SiteOne will invest $18 million in the combined company, with a group led by investment firm Murchinson kicking in another $32 million. — Ben Fidler Bayer on Wednesday debuted a 70,000-square-foot expansion to a Myerstown, Pennsylvania, facility that now represents the largest manufacturing site for its consumer health division. The expansion follows a $44 million investment in 2022 and will help the company more efficiently manufacture products like Aspirin, Claritin and Midol. The facility employs more than 585 full-time workers, according to a published report.— Ben Fidler RNA editing startup Airna has named former Sarepta Therapeutics executive Jacob Elkins as its chief medical officer. Elkins was most recently Sarepta's CMO and head of development sciences, and in that role helped support the development of the company's 'exon skipping' RNA therapies and the Duchenne muscular dystrophy gene therapy Elevidys. At Airna, he'll oversee development of an experimental treatment for alpha-1 antitrypsin deficiency that's nearing human testing, and help expand the company's pipeline into more common conditions as well. — Ben Fidler Recommended Reading JPM25: The FDA's future, AbbVie's second thoughts and Lilly's lesson Sign in to access your portfolio
Yahoo
21-02-2025
- Business
- Yahoo
Ozempic, Wegovy shortage resolved; Pfizer CEO is PhRMA's new chair
This story was originally published on BioPharma Dive. To receive daily news and insights, subscribe to our free daily BioPharma Dive newsletter. Today, a brief rundown of news involving Novo Nordisk, Acelyrin and Intra-Cellular Therapies, as well as updates from Gilead Sciences and PhRMA that you might have missed. The Food and Drug Administration has declared a two-and-a-half year shortage of Novo Nordisk's metabolic drugs Ozempic for diabetes and Wegovy for obesity to be 'resolved,' as of Friday. The decision follows the FDA's declaration of an end to shortages for Eli Lilly's competing drugs Mounjaro and Zepbound. The two companies have struggled with capacity as demand for the drugs has soared, particularly in obesity. To ensure supplies of compounded alternatives of the Novo drugs aren't disrupted, the FDA said it won't enforce any bans on those products until April 22 if manufactured at a state-licensed pharmacy or May 22 if they're made at a federally authorized outsourcing facility. Shares in Hims & Hers Health, which has marketed compounded versions of the drugs, fell by more than 20% in Friday morning trading. — Jonathan Gardner Concentra Biosciences, an entity controlled by investment firm Tang Capital Partners, has made an unsolicited bid for Acelyrin weeks after the company agreed to merge with fellow immune drug developer Alumis. Through the offer announced Thursday, Concentra intends to acquire Acelyrin for $3 per share in cash as well as the right to 80% of the proceeds if Concentra licenses or sells the company's programs. Acelyrin stockholders would get about 45% of Alumis' shares — which currently trade around $5 apiece — in the planned merger. Acelyrin said its board will act in 'the best interests of all stockholders' and it will make a further announcement 'in due course.' If approved by shareholders, its merger with Alumis would close in the second quarter. — Ben Fidler Intra-Cellular Therapies, maker of the mind-stabilizing medicine Caplyta, reported on Friday that net sales of the product totaled almost $681 million last year. That sum is up 47% compared to 2023. Caplyta is already approved in the U.S. as a treatment for schizophrenia and bipolar depression, and could be cleared in major depression before too long. Sensing the drug's blockbuster potential, Johnson & Johnson recently agreed to acquire Intra-Cellular for nearly $15 billion. The deal is expected to close later this year. — Jacob Bell European regulators have granted conditional authorization to Gilead Sciences' seladelpar in primary biliary cholangitis, a rare autoimmune condition of the liver. The European Commission's decision follows by six months the Food and Drug Administration's decision to grant accelerated authorization to the drug, which Gilead sells as Livdelzi in the U.S. Testing showed seladelpar reduced levels of a liver enzyme that is elevated in PBC patients. To gain full approval, Gilead is working on a confirmatory trial designed to show seladelpar can reduce PBC-related complications in people with the condition and compensated cirrhosis. The company gained the drug in its $4.3 billion acquisition of . — Jonathan Gardner Pfizer CEO Albert Bourla has assumed the role of chair of the Pharmaceutical Research and Manufacturers of America's board. Bourla, who has been Pfizer's CEO since 2019, said he wants drugmakers' biggest lobbying group to work with policymakers to 'address the burden of chronic disease and other devastating conditions, improve patients' lives, and ensure lifechanging medicines are available and affordable for people who need them.' Bourla will take PhRMA's reins from Gilead Sciences CEO Daniel O'Day. Sanofi CEO Paul Hudson was elected as PhRMA's chair-elect and Merck & Co.'s CEO Robert Davis will serve as treasurer.— Jonathan Gardner Incyte and Genesis Therapeutics are teaming up on an AI collaboration the companies said will help them find new small molecule drug candidates more quickly. Announced Thursday, the deal hands Genesis $30 million upfront with the potential for $295 million more upon hitting certain milestones. If successful, Incyte retains the rights to develop and commercialize any drugs that emerge from the partnership. Neither company said which disease area would be pursued first. — Gwendolyn Wu Sign in to access your portfolio
