Contract development & manufacturing organization Althea, an Ajinomoto company, announced today the launch of a new, high-performance sterile vial filling line. The Optima VFVM 7000 aseptic fill finish line adds to Althea’s drug product manufacturing capabilities and enables the company to work with larger batch sizes and a broader range of filling volumes – up to […]
Contract Manufacturing
TSO3 rebounds after short-seller’s report triggers plunge
Share prices for TSO3 (TSE:TOS) rebounded somewhat today after taking a beating yesterday on a short-seller’s report questioning the company’s stability. The short seller, Spruce Point Mgmt., accused the Canadian company of not disclosing the installed customer base for its Sterizone VP4 sterilizer as promised this year because, “if it did, investors might see just […]
Manufacturing drug device products: challenges and best practices
Integrating a drug with a mechanical device can, in some cases, improve patient outcomes and boost sales. But manufacturing these products is no simple feat: It often requires a specialized contract manufacturer with extensive experience in the field to make a drug-device combo buildable and scalable. There’s a lot to consider when manufacturing a medical […]
Aerie’s contract manufacturer faces regulatory hurdle
Aerie Pharmaceuticals (NSDQ:AERI) said today that its contract manufacturer received a complete response letter from the FDA regarding a regulatory application for one of the manufacturer’s own product candidates. The rejection letter reportedly cites a CGMP inspection at the facility as reasoning for the CRL. The facility also manufactures Aerie’s Rhopressa ophthalmic solution, which the FDA […]
Why the medtech contract manufacturing M&A trend isn’t slowing down
Consolidation is increasingly shaping the medical device industry, but what about players on the other side of the fence? Medtech contract manufacturing partners to OEMs are seeing their own abundance of M&A as larger players look to expand their influence and keep up with increasing demand. Over the past four years, the medical device industry […]
Integer Holdings: What you need to know
Greatbatch and Lake Region Medical merged nearly two years ago to become Integer Holdings Co., a giant medical device contract manufacturer that could theoretically do almost anything for an OEM. But can this colossus of a company execute on its expanded capabilities? When Greatbatch and Lake Region Medical merged in 2015, company officials decided they […]
Freudenberg Medical spends $10M to expand Irish catheter plant
Freudenberg Medical today announced that its VistaMed joint venture company has spent €9 million, equivalent to about $10 million, expanding its Carrick-on-Shannon, Ireland catheter manufacturing facility. The expansion added 45,000 square feet – including four additional ISO Class 7 cleanrooms – to VistaMed’s existing plant in Carrick-on-Shannon. The project enables VistaMed to better meet demand when it […]
These wheelchair wheels function like airplane landing gear
Frog Legs has partnered with PlastiComp to make carbon fiber composite wheelchair caster wheels that function like airplane landing gear for a smoother ride. Frog Legs wanted to switch the wheels of its wheelchairs from machined aluminum to carbon fiber composite. Mark Chelgren, the company’s founder, also wanted to create a wheelchair that had a […]
Integer misses expectations on Q2 profits, but grows revenue
Medical device contract manufacturing giant Integer Holdings Co.(NYSE: ITGR) reported a mixed bag when it came to second-quarter results. Nearly two years after Greatbatch and Lake Region Medical merged to create Frisco, Texas–based Integer, sales are growing, but second-quarter profits did not meet analysts’ expectations, according to earnings released yesterday evening. Integer earned $3.0 million, […]
Wisconsin biotech industry optimistic about state’s Foxconn win
Wisconsin’s biotech industry sees opportunity in Taiwanese electronics giant Foxconn’s decision to spend $10 billion on a 3,000-employee plant in the state’s southeast. That’s because the 8K liquid crystal display (LCD) screens made at the new Foxconn campus could enable new medical solutions for surgical procedures, according to BioForward Wisconsin. “BioForward and Wisconsin’s biohealth community welcomes […]
Icon beats Street on Q2 earnings, acquires Mapi Group
Drug development provider Icon PLC (Nasdaq: ICLR) saw its stock jump about 6% in value today after announcing second-quarter earnings that beat analysts’ expectations. The Dublin, Ireland–based company, which serves the pharmaceutical, biotechnology and medical device industries, also said it has acquired the Mapi Group, which provides patient-centered health outcomes research and commercialisation. Financial terms of […]