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Health Canada OK’s Alnylam’s Oxlumo for Ultra-rare…

Health Canada has approved Alnylam’s Oxlumo (lumasiran) injection for subcutaneous use for the treatment of primary hyperoxaluria type 1 (PH1) to lower urinary oxalate levels in pediatric and adult patientsThe Notice of Compliance (NOC) authorizing use of Oxlumo was issued based on results from the ILLUMINATE-A study in patients six years and older with PH1 and the ILLUMINATE-B study in patients under six years with PH1Alnylam’s Canada Medical Director Dr. Kristopher Garlick commented, “Previously there have been no authorized treatment options for PH1 in Canada, so this is a potentially life-changing milestone for people diagnosed with this debilitating disease – many of whom are infants and children”

Kyowa Kirin and LUCA to Co-develop Innovative Drugs…

Kyowa Kirin and LUCA Science are teaming up to develop an innovative treatment for mitochondrial diseasesThe deal involves Kyowa leveraging LUCA’s proprietary functional mitochondria therapy platform to come up with an innovative mitochondrial modalitySpecifically, LUCA will use its platform to manufacture, store, and deliver innovative mitochondrial drugs for a wide range of diseases with no effective treatments

FDA Authorizes Comirnaty Boost for 5-11 Year Olds

The U.S. Food and Drug Administration (FDA) has amended the Emergency Use Authorization (EUA) for Pfizer and BioNTech’s COVID-19 vaccine, Comirnaty to include a booster dose for children ages 5 through 11 at least five months after their primary vaccination with ComirnatyThe FDA analyzed immune response data in a subset of children from the ongoing randomized placebo-controlled trail that supported the agency’s authorization of Comirnaty in children five to 11 years of age, finding those who received the booster had increased antibody levels compared to before the dose Comirnaty has now been authorized for individuals aged five years and up since October 2021, while it is fully approved for use in individuals aged 16 years and up

More Canadian Provinces List Ajovy in Public…

Ontario, British Columbia, Nova Scotia, New Brunswick, and Newfoundland are now including Ajovy (fremanezumab) for the preventative treatment of migraine on their public formulariesToday’s announcement follows word from Teva in March, stating that Alberta, Saskatchewan, Quebec, Veteran Affairs Canada (VAC) and the Non-Insured Health Benefits (NIHB) Program had decided to list Ajovy on public formulariesAjovy is administered via subcutaneous injection for the preventative treatment of migraine in adults who have at least four migraine days per month

EUCOPE Hopes Joint EU HTA Will Reduce Burden,…

EUCOPE hopes that a Joint European Union Health Technology Assessment (HTA) system will reduce burden and complexities, and facilitate accessIn 2021, the European Council and the European Parliament, reached a provisional agreement, signing off the implementation of a regulation that will “dramatically reduce duplications of clinical assessments, ensure sustainable cooperation on HTA and provide us with a framework to better face health issues, such as rare diseases, personal medicine, and orphan medicines,” according to German MEP, Tiemo WölkenHowever, speaking to Pharma Boardroom, EUCOPE’s Secretary-General Dr. Alexander Natz says there are both “opportunities and pitfalls” with the EU HTA procedure, he explained, “the next three years will decide the crucial steps and whether the new procedure leads to reduced burdens for developers and faster patient access to innovative therapies”

China Approves Homegrown PD-1 Inhibitor Tuoyi in 5th…

The National Medical Products Administration (NMPA) of China has approved Junshi Bio’s PD-1 inhibitor, Tuoyi (toripalimab), in combination with paclitaxel and cisplatin, for the first-line treatment of patients with unresectable locally advanced, recurrent, or distant metastatic esophageal squamous cell carcinoma (ESCC)In the Phase 3 JUPITER-06 clinical trial, Tuoyi plus chemotherapy achieved greater overall survival (OS) in patients with ESCC as opposed to placebo plus chemotherapy—OS was prolonged by 17 months and the risk of disease progression or death was reduced by 42%, regardless of PD-L1 expressionToday’s announcement marks the fifth approval for Tuoyi in China, following conditional approvals in melanoma, nasopharyngeal carcinoma (NPC), and urothelial carcinoma, as well as full approval in NPC

Amgros Will No Longer Post Prices of “New Expensive…

In an email to EVERSANA’s Tender department, the pharmaceutical procurement service for the five regional authorities in Denmark (Amgros) clarified that as of April 1, 2022, it will no longer be publishing the prices of “new expensive hospital pharmaceuticals and biologicals.” The agency explained, “The new agreements that started from 1 April 2022 are with non-public prices. Therefore, the prices are not available”Amgros elaborated, “Whether a price is public or not from Amgros depends on a specific assessment depending on the market, the competition, the type of drug and input from external stakeholders, medicinal suppliers and hospital pharmacies, etc”The NAVLIN team is aware of the change and will continue to publish any prices that Amgros makes publicly available. NAVLIN’s Tender Solution is a state-of-the-art tender database with simulation capabilities to help companies strategize for successful bidding, not only in Europe but in other regions as well, covering 40+ markets overall and expanding. Given the competitive nature of tendering, especially as more generic products continue to enter the market, planning is crucial for securing a contract that is optimal for both companies and buyers

Suzhou Hospital Conducts Clinical Trial of Yescarta in…

The First Affiliated Hospital of Soochow University is conducting a clinical trial of Fosun Kite’s FKC876 – A.K.A. Yescarta (axicabtagene ciloleucel) – in adult patients with relapsed/refractory non-Hodgkin’s lymphoma (iNHL)The goal of the clinical trial is to support the approval of new indications for Yescarta, which was the first CAR-T cell therapy to garner a regulatory nod in ChinaIn June 2021, the National Medical Products Administration (NMPA) approved the CAR-T therapy for adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy

Singapore Clears SCG’s IND for Clinical Trials of…

The Health Sciences Authority (HSA) of Singapore has approved SCG Cell Therapy’s Investigational New Drug (IND) application for clinical trials of SCG101 for the treatment of hepatitis B virus (HBV)-related hepatocellular carcinoma (HCC)The China National Medical Products Administration (NMPA) cleared SCG’s IND for the TCR T-cell therapy in MarchIn November 2021, it was announced that SCG had signed an agreement with the Cell Therapy Facility of Singapore Health Sciences Authority (HSA-CTF) for the evaluation and validation of the company’s proprietary cell therapy manufacturing process to develop this treatment of HBV-related HCC

JIXING Obtains Global Rights to Hovione’s…

Lisbon-based Hovione has announced an exclusive license agreement with Ji Xing Pharmaceuticals Limited (JIXING) for its preclinical ophthalmology program, JX08Under the agreement, Shanghai-based JIXING is receiving global rights to JX08 and will lead the full life cycle of development, from preclinical through commercialization stagesPeter Fong, PhD, Board Executive Director, JIXING, said, “We are excited to partner with Hovione and today’s agreement further strengthens JIXING’s ophthalmology pipeline beyond its current focus on presbyopia and dry eye disease”

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