GSK withstands Advair generics, thanks to new respiratory meds and Shingrix

Fiercepharma | July 24, 2019

GlaxoSmithKlines been dreading generic Advair for years, but thanks to its newer respiratory meds and the fast-launching Shingrix vaccine, the companys top line is so far managing to hold its own. Mylan launched Wixela Inhub, the first true Advair copycat, in February, and sales of the GSK behemoth plummeted a whopping 61% in the U.S. in the second quarter, to merely £105 million ($131 million). And the new generic put pricing pressure on all similar products, dealing a blow to the rest of GSK's respiratory franchise. Overall, sales of newer respiratory drugs—not counting established meds such as Advair and Ventolin—dropped 2% in the U.S. for the quarter. Still, strong growth from triple-combo Trelegy and biologic Nucala helped push GSK's newer respiratory therapies up by 12% to £752 million. That, along with Shingrix's continued surge and aid from its HIV franchise pushed GSK sales up 5% at constant exchange rates to £7.8 billion. Nucala racked up £195 million in the quarter, up 33% at unchanged currencies and 10% ahead of analysts’ consensus as quoted by Jefferies. In June, the FDA approved two new self-administered versions of Nucala—an autoinjector and a prefilled syringe—helping level the ground in its competition with AstraZeneca’s rival med Fasenra. But the AZ drug, which already boasts a dosing frequency advantage over Nucala—once every eight weeks for Fasenra versus once every four weeks for Nucala—is not far behind. A few days ago, it received EMA backing for its own autoinjector option and is expecting an FDA decision soon this year.

Spotlight

Injection systems that are attached to the patient's body (on-body delivery system OBDS) minimize possible risks, that can occur when drugs are administered by conventional needle-based injection systems (NIS). 

Spotlight

Injection systems that are attached to the patient's body (on-body delivery system OBDS) minimize possible risks, that can occur when drugs are administered by conventional needle-based injection systems (NIS). 

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Pharmacy Market

AIS Healthcare’s Advanced Infusion Care Announces Opening of Cockeysville, Maryland Pharmacy

Businesswire | August 16, 2023

Advanced Infusion Care (AIC), a division of AIS Healthcare, today announced the opening of a new pharmacy location in Cockeysville, Maryland. This continued expansion to the Northeast provides a platform for the company to serve more patients and physicians in the region. The Maryland pharmacy is AIC’s sixth location from which the company dispenses essential medications and personalized care to patients across the United States with complex medical conditions like immune deficiency diseases. The newly opened pharmacy is strategically positioned and designed to cater to the unique needs of patients and providers in the Mid-Atlantic. With a firm commitment to elevating the patient experience, AIC aims to make medications and home infusion services more accessible to those in need of care solutions. "We are thrilled to open a pharmacy location in Maryland. This expansion is a testament to AIC’s unwavering dedication to our patients and our vision of providing best-in-class healthcare services with a personal touch. By opening this location, we aim to streamline the medication fulfillment process, enhance convenience, and ultimately improve the lives of our patients,” said Jud Hall, President at AIC. With a focus on efficiency and compassion, AIC is committed to addressing the unique medication needs of each patient and fostering strong relationships with healthcare providers in the area. The fully operational pharmacy in Maryland has started dispensing its extensive inventory of prescription medications, over-the-counter products, and specialty medications to patients. The location utilizes cutting-edge technology and a team of highly skilled pharmacists and healthcare professionals to serve patients. The facility also features a state-of-the-art USP797-compliant cleanroom, which is critical to ensuring sterility and quality in the medications. In recent months, AIC announced further expansion into the New England market and the grand reopening of a newly designed pharmacy in Valdosta, Georgia. AIC also made medications like GAMMAKED™ and LEQEMBI™ available to patients through its locations in Valdosta, Georgia; Birmingham, Alabama; Clinton, Mississippi; Panama City, Florida; and Dallas, Texas. About AIS Healthcare As the leading provider of targeted drug delivery and infusion care solutions, AIS Healthcare is committed to doing more of what matters. From pharmacies that put patient safety first to comprehensive services that enhance the entire care experience, we go beyond the expected in everything we do.

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PHARMACY MARKET, PHARMA TECH

Kindeva Drug Delivery, Chiesi Group, and H&T Presspart Announce Strategic Partnership for Dose Counter Technology Production

Businesswire | July 12, 2023

Kindeva Drug Delivery, a global leader in contract drug delivery development and manufacturing services and technology, and H&T Presspart (a division of the Heitkamp & Thumann Group), a market leader in respiratory drug delivery systems design, development, and manufacturing, are partnering with Chiesi Group, an international research-focused biopharmaceutical and healthcare group, for the installation of a production line for dose counter (DC) and dose indicator (DI) devices. Combining the specific expertise of each partner, H&T Presspart will manufacture Kindeva Drug Delivery’s dose counters under license for Chiesi Group for their pressurized metered-dose inhaler (pMDI) portfolio. This partnership is a continuation of the agreement signed in 2014 between Kindeva Drug Delivery and H&T Presspart to accelerate the growth of Kindeva Drug Delivery’s dose counter technology. This technology enhances patient safety by providing real-time information on the remaining doses in inhalers, preventing unexpected shortages. H&T Presspart will expand the cleanroom facilities at their Marsberg, Germany, site to support the dose counter production. As part of this strategic partnership, Chiesi Group will use dose counters in their innovative carbon minimal pMDI portfolio, which uses a low Global Warming Potential (GWP) propellant to minimize the climate impact of the inhalers, while maintaining all the therapeutic options that patients suffering from respiratory diseases need. David Stevens, global chief commercial officer of Kindeva Drug Delivery, stated: “Kindeva is pleased to extend this strategic partnership as it solidifies our core objective of improving the lives of patients around the world. Kindeva embraces the responsibility it has in ensuring that patients who depend upon our device technology are reliably supplied, and we believe that this innovative supply chain collaboration further underscores this commitment.” Roberto Della Valle, head of global direct procurement of Chiesi Group, added: “Chiesi, with its patient-centric approach, is dedicated to delivering therapeutic solutions that enhance patients’ health and quality of life. Collaborating with Kindeva and H&T Presspart exemplifies this commitment, and we are thrilled to take this step forward. By providing an inhaler that reassures patients about the remaining dose count, we aim to enhance their safety and confidence.” Christian Kraetzig, president of H&T Presspart, commented: “With our expertise in device industrialization and manufacturing, this agreement marks another step in our journey to becoming a leading development and contract manufacturing partner in drug delivery devices.” About Kindeva Drug Delivery Kindeva Drug Delivery is a global contract development manufacturing organization focused on drug-device combination products. Kindeva Drug Delivery develops and manufactures products across a broad range of complex drug-delivery formats, including injectables (autoinjector, intradermal, microneedle), pulmonary & nasal, and transdermal patches. Its service offering spans early-stage feasibility through commercial scale drug product fill-finish, container closure system manufacturing, and drug-device product assembly. Kindeva Drug Delivery serves a global client base from its nine manufacturing and research and development facilities located in the U.S. and U.K. About Chiesi Group Chiesi is an international, research-focused biopharmaceuticals group that develops and markets innovative therapeutic solutions in respiratory health, rare diseases, and specialty care. The company’s mission is to improve people’s quality of life and act responsibly towards both the community and the environment. By changing its legal status to a Benefit Corporation in Italy, the US, and France, Chiesi’s commitment to create shared value for society as a whole is legally binding and central to company-wide decision-making. As a certified B Corp since 2019, we’re part of a global community of businesses that meet high standards of social and environmental impact. The company aims to reach Net-Zero greenhouse gases (GHG) emissions by 2035. With over 85 years of experience, Chiesi is headquartered in Parma (Italy), operates in 31 countries, and counts more than 6,500 employees.

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Pharmacy Market

Nexus Pharmaceuticals Receives FDA Approval for 0.9% Sodium Chloride Injection

businesswire | August 31, 2023

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