Grifols | MedPath

FDA Grants IND Clearance for Immunoglobulin Eye Drops to Treat Dry Eye Disease

a day ago

• The FDA has granted Investigational New Drug clearance for immunoglobulin eye drops (SLG-100/GRF312), developed by Selagine and Grifols, to treat dry eye disease in upcoming Phase II clinical trials. • The novel treatment offers broad-spectrum anti-inflammatory and immunomodulatory properties, potentially providing mechanistic superiority over current narrow-spectrum therapies that primarily target T-cell inflammation. • A first-in-human pilot trial demonstrated significant reduction in dry eye symptoms with no difference in tolerability or adverse events compared to vehicle, showing promise for the over 100 million people affected globally.

IBL International and Grifols Form Strategic Partnership to Advance Specialty Diagnostics with Novel Biomarker Panels

8 days ago

• IBL International and Grifols have partnered to develop specialized biomarker panels utilizing Grifols' single molecule counting (SMC) platform, aiming to address critical gaps in specialty diagnostics. • The collaboration leverages IBL's expertise in diagnostic assay development with Grifols' instrumentation capabilities, establishing a framework for development, manufacturing, and commercialization of new diagnostic solutions. • This strategic alliance represents a significant advancement in laboratory diagnostics, promising to enhance clinical workflows and improve patient care through more reliable and sensitive diagnostic tools.

FDA Approves Dupilumab for Chronic Spontaneous Urticaria, Expanding Treatment Options

a month ago

• The FDA has approved Sanofi and Regeneron's dupilumab (Dupixent) for the treatment of chronic spontaneous urticaria in patients inadequately controlled with existing therapies. • Dupilumab becomes the first biologic targeting IL-4 and IL-13 pathways approved for chronic urticaria, offering a new mechanism of action for patients with limited treatment options. • The approval is based on positive Phase 3 clinical trial results demonstrating significant reduction in itch and hives compared to placebo in this difficult-to-treat patient population.

Trump's Executive Order Delays Medicare Drug Price Negotiations, Sparking Industry and Policy Debate

a month ago

• President Trump signed an executive order extending the exemption period for small-molecule drugs from Medicare price negotiations by four years, a move criticized by advocacy groups as favoring pharmaceutical industry interests. • The order aims to address what the administration calls the "pill penalty" - the current policy where small-molecule drugs (90% of medications) face negotiations after 9 years while biologics have longer exemption periods. • The Medicare Drug Price Negotiation Program, established under the Biden administration, had already achieved price reductions of 38-79% on 10 high-cost drugs with projected savings of $6 billion if applied in 2023.

Merck's Subcutaneous Pembrolizumab Shows Comparable Efficacy to IV KEYTRUDA with Significantly Reduced Administration Time

2 months ago

• Merck's subcutaneous pembrolizumab with berahyaluronidase alfa demonstrated noninferior pharmacokinetics compared to intravenous KEYTRUDA in a pivotal Phase 3 trial for metastatic non-small cell lung cancer treatment. • The subcutaneous formulation, administered in approximately two minutes versus standard IV infusion, reduced patient chair time by nearly 50% and healthcare professional active time by 45.7%, potentially improving treatment efficiency. • FDA review of the subcutaneous pembrolizumab application is underway with a target action date of September 23, 2025, which could make it the first subcutaneous checkpoint inhibitor available across all KEYTRUDA's approved solid tumor indications.

Grifols' Immunoglobulin Therapy Shows Promising Results in Post-Polio Syndrome Clinical Trial

2 months ago

• A one-year clinical trial of Grifols' intravenous immunoglobulin therapy Flebogamma 5% DIF demonstrated significant mobility improvements in post-polio syndrome patients, with treated participants walking 12.75 meters farther in the two-minute walk test. • The phase 2/3 study involving 191 participants met its primary endpoint, showing the treatment can halt and even reverse the previously considered inevitable physical decline associated with post-polio syndrome. • Post-polio syndrome affects 25-40% of polio survivors years after initial infection, with an estimated 12-20 million survivors worldwide at risk, and until now, treatment options were limited to symptom management.

Biotech Deal Landscape: February-March 2025 Sees Surge in Partnerships Across Multiple Therapeutic Areas

2 months ago

• The first quarter of 2025 witnessed significant biotech partnership activity, with Eli Lilly, AstraZeneca, and Novo Nordisk emerging as top collaborators in deals worth billions across small molecules, antibodies, and RNA therapeutics. • February 2025 featured notable acquisitions including Novartis's $2.15 billion buyout of Anthos Therapeutics, while March saw AstraZeneca acquire Belgian biotech EsoBiotec and Bristol Myers Squibb purchase 2seventy bio for $286 million. • Obesity therapeutics gained significant traction in March 2025, with AbbVie entering the field through a $350 million upfront deal with Gubra for an amylin analog, while Roche partnered with Zealand Pharma on petrelintide in a deal worth up to $5.25 billion.

North Carolina Emerges as Global Bioscience Hub with $2.5B International Investment Surge

3 months ago

• North Carolina has attracted 71 international life science companies from 20 countries, generating over $2.5 billion in investments and creating 17,000 jobs in the past five years. • Novo Nordisk leads the expansion with a historic $1.8 billion manufacturing facility in Clayton, representing the largest single manufacturing investment in North Carolina's history. • Major international companies including Aurobindo Pharma, Grifols, and FUJIFILM Diosynth have established or expanded operations, drawn by the state's research infrastructure, skilled workforce, and strategic location.

Pfizer Discontinues Beqvez Gene Therapy for Hemophilia B Amid Low Market Demand

3 months ago

• Pfizer has announced the cessation of development and commercialization of Beqvez, its FDA-approved gene therapy for hemophilia B, citing limited interest from patients and healthcare providers. • The decision marks Pfizer's complete exit from viral gene replacement therapies, following earlier withdrawals from Duchenne muscular dystrophy and hemophilia A programs. • The company will shift focus to other treatments including Hympavzi for hemophilia A, while maintaining support for existing Beqvez clinical trial participants.

Grifols Receives $21 Million Grant to Identify Parkinson's Disease Biomarkers

4 months ago

• Grifols has been awarded a $21 million grant from the Michael J. Fox Foundation to discover plasma-based biomarkers for Parkinson's disease. • The Chronos PD study will analyze over 100 million biospecimens to identify early risk indicators and potential therapeutic targets. • The initiative aims to develop new diagnostic tools and disease-modifying therapies by tracking plasma protein evolution over a decade. • Grifols' subsidiary, Alkahest, will lead the AI-driven analysis of multiomics data to accelerate biomarker discovery.

Biotest Submits Fibrinogen Biologics License Application to FDA

4 months ago

• Biotest has submitted a Biologics License Application (BLA) to the FDA for its Fibrinogen product, addressing acquired fibrinogen deficiency. • The application includes treatment and prophylaxis of acute bleeding episodes in patients with congenital fibrinogen deficiency, expanding its potential use. • Clinical data supports the efficacy and safety of Biotest's Fibrinogen, offering advantages over current treatments like fresh frozen plasma. • The FDA is expected to make a decision by the end of 2025, following a similar application submitted in Europe in October 2024.

FDA Wraps Up 2024 with Key Approvals for Drugs Targeting Various Conditions

6 months ago

• The FDA approved Vertex's Alyftrek for cystic fibrosis, offering improved dosing and potential market exclusivity. • Novo Nordisk's Alhemo was approved for hemophilia A and B, providing a new option for patients with inhibitors. • Bristol Myers Squibb's Opdivo Qvantig gained approval as a subcutaneous formulation, offering faster administration for various solid tumors. • Eli Lilly's Zepbound secured approval for obstructive sleep apnea in obese adults, marking the first prescription medicine for this condition.

GigaGen Initiates Phase I Trial of GIGA-2339 for Chronic Hepatitis B

6 months ago

• GigaGen, a Grifols subsidiary, has begun a Phase I clinical trial for GIGA-2339, a recombinant polyclonal antibody drug, in patients with chronic HBV infection. • The Phase I trial will assess the safety and tolerability of GIGA-2339, which comprises over 1,000 lab-engineered anti-HBV antibodies mimicking vaccinated donors' natural response. • Preclinical data suggest GIGA-2339 neutralizes and eliminates HBV viral antigens and DNA, potentially offering a functional cure by clearing viral particles and stimulating the immune system. • GIGA-2339's mechanism targets a broad spectrum of HBV variants and boasts over 2,000 times greater potency than plasma-derived HBV treatments, according to the company.

GigaGen Initiates Phase I Trial of GIGA-2339 for Chronic Hepatitis B

6 months ago

• GigaGen, a Grifols subsidiary, has commenced a Phase I dose escalation trial of GIGA-2339 for chronic HBV infection. • GIGA-2339 is a recombinant polyclonal antibody drug candidate composed of over 1,000 anti-HBV antibodies, designed to mimic the natural immune response. • Preclinical studies suggest GIGA-2339 can neutralize and eliminate HBV viral antigens and DNA, potentially offering a functional cure. • The Phase I trial will evaluate the safety and tolerability of GIGA-2339 in individuals with confirmed chronic HBV infection.

Roche to Acquire Poseida Therapeutics; Merck, AstraZeneca, and Novartis Report Pipeline Success

6 months ago

• Roche will acquire Poseida Therapeutics for $1.0 billion, expanding its CAR-T therapy portfolio, targeting hematological malignancies, solid tumors, and autoimmune diseases. • Merck's Winrevair phase III study met its primary endpoint, showing a statistically significant reduction in morbidity or mortality events in advanced pulmonary arterial hypertension. • AstraZeneca's Truqap, combined with Zytiga and ADT, significantly improved radiographic progression-free survival in PTEN-deficient metastatic hormone-sensitive prostate cancer. • Novartis received European Commission approval for Kisqali to treat HR+/HER2- early breast cancer patients at high risk of disease recurrence, based on the NATALEE phase III trial.

Grifols' VISTASEAL Receives FDA Approval for Pediatric Surgical Bleeding

7 months ago

• Grifols' fibrin sealant (FS), VISTASEAL, gains FDA approval for controlling surgical bleeding in pediatric patients, expanding its availability in the U.S. • The approval is based on a Phase 3b study demonstrating over 95% efficacy in achieving hemostasis within four minutes in pediatric patients. • VISTASEAL combines human fibrinogen and thrombin, applied using Johnson & Johnson MedTech's airless spray technology to rapidly form clots. • Disruptive bleeding occurs in one-third to two-thirds of open surgeries, making VISTASEAL a crucial adjunct when standard techniques are insufficient.

FDA Approves VISTASEAL Fibrin Sealant for Pediatric Surgical Bleeding

7 months ago

• The FDA has approved VISTASEAL, a fibrin sealant from Grifols, for controlling surgical bleeding in pediatric patients. • VISTASEAL combines fibrinogen and thrombin proteins to promote hemostasis and tissue sealing during surgery, reducing blood loss. • A Phase 3b study demonstrated VISTASEAL's efficacy in achieving hemostasis within 4 minutes in over 95% of pediatric patients. • VISTASEAL is contraindicated for intravascular injection or use in patients with anaphylaxis to human blood products.

Grifols' Fibrin Sealant Gains FDA Approval for Pediatric Surgical Bleeding

7 months ago

• Grifols' fibrin sealant (FS) has been approved by the FDA for use in pediatric patients undergoing surgery to control bleeding, expanding its availability in the U.S. • The approval is based on a Phase 3b study demonstrating the safety and efficacy of Grifols FS in achieving hemostasis within four minutes in pediatric surgical patients. • VISTASEAL™/VERASEAL™, Grifols' FS biosurgery treatment, combines fibrinogen and thrombin to promote clot formation and reduce blood loss during surgical procedures. • Marketed and distributed by Johnson & Johnson MedTech, Grifols FS is now available in 18 countries, offering an innovative solution for managing surgical bleeding in young patients.

Grifols' Fibrin Sealant VISTASEAL™ Receives FDA Approval for Pediatric Surgical Bleeding

7 months ago

• Grifols' VISTASEAL™ fibrin sealant secures FDA approval for managing surgical bleeding in pediatric patients in the U.S. • A Phase 3b trial demonstrated over 95% efficacy in achieving hemostasis within four minutes of VISTASEAL™ application. • This approval expands VISTASEAL™ availability, already approved in Europe, enhancing surgical outcomes for younger patients. • VISTASEAL™ is distributed through a strategic partnership with Johnson & Johnson MedTech and is available in 18 countries.

FDA Approves Expanded Label for Grifols' Xembify, Allowing Treatment-Naïve PI Patients Subcutaneous Immunoglobulin Therapy

10 months ago

• The FDA has approved an expanded label for Grifols' Xembify, a 20% subcutaneous immunoglobulin, to include treatment-naïve patients with primary humoral immunodeficiencies (PI). • Xembify is the first 20% SCIg with this extended label, which eliminates the need for initial intravenous treatment for patients starting SCIg therapy. • The approval also includes biweekly dosing, supported by phase 4 clinical trial data demonstrating non-inferiority in total Ig levels compared to weekly dosing. • Grifols plans to launch the new label in the U.S. in Q3 2024, offering patients greater convenience and flexibility with biweekly dosing.