ALPI Solutions

ALPI Solutions Smart Pharmaceutical Consulting | Regulatory Affairs | Market Research | Field Force Solutions

Two FDA Wins This Week: Wegovy for Liver Disease, and the First New Fibromyalgia Drug in 15 Years (Tonmya)! • Wego...
08/21/2025

Two FDA Wins This Week: Wegovy for Liver Disease, and the First New Fibromyalgia Drug in 15 Years (Tonmya)!
• Wegovy for MASH — promising new direction in liver health.
• Tonmya — a breakthrough for fibromyalgia sufferers everywhere.

It’s inspiring to see innovation moving ahead across both metabolic and chronic pain conditions.

What excites you the most about these approvals?

FDA Launches “PreCheck” to Fast-Track U.S. Drug Manufacturing ApprovalsThe FDA has introduced PreCheck, a new initiative...
08/14/2025

FDA Launches “PreCheck” to Fast-Track U.S. Drug Manufacturing Approvals

The FDA has introduced PreCheck, a new initiative designed to accelerate the review and approval of pharmaceutical manufacturing in the United States.

This program aims to:
✅ Speed up time-to-market for essential medicines
✅ Support domestic manufacturing capacity
✅ Strengthen supply chain resilience

For patients, it means faster access to critical treatments. For manufacturers, it’s an opportunity to bring innovation to market with reduced delays.

💊 FDA has approved Sebience — the first oral PKU therapy!Phenylketonuria (PKU) is a rare condition where the body can’t ...
08/05/2025

💊 FDA has approved Sebience — the first oral PKU therapy!

Phenylketonuria (PKU) is a rare condition where the body can’t break down phenylalanine. Now, patients can manage symptoms with an on-demand oral drug — acting in just 1.6 hours .

This is a big step for rare disease treatment accessibility — oral dosage, faster relief, more convenience.

We’re excited to see how this innovation changes the landscape for patients and pharma alike.

🚨 New EU–US Deal Could Mean 15% Tariffs on PharmaceuticalsA recent trade agreement might impose a 15% tariff on branded ...
07/31/2025

🚨 New EU–US Deal Could Mean 15% Tariffs on Pharmaceuticals

A recent trade agreement might impose a 15% tariff on branded drugs imported from the EU—something pharma companies were previously exempt from . Analysts estimate this could raise costs by up to $19 billion.

📌 What to watch:
• How will companies adapt pricing strategies?
• Could supply chain routes and inventory plans change?
• What new risks will Field Force face in delivery and availability?

👉 What could this mean for pharma supply and market access policies?

🚨 FDA Now Inspects Every Import – Even Small PackagesStarting July 9, FDA will check all imported items — no more exempt...
07/24/2025

🚨 FDA Now Inspects Every Import – Even Small Packages

Starting July 9, FDA will check all imported items — no more exemptions for packages under $800 .

That means delays might impact:
✅ Field Force — product availability
✅ Tiny-value imports — like samples or devices
✅ Regulatory documentation and compliance!

At ALPI Solutions, we help teams prepare for this change and keep supply chains smooth.

Is your team ready for enhanced FDA border scrutiny?
💬 Share your thoughts!

FDA said no — not to the drug, but to the paperwork.Ultragenyx’s promising gene therapy for Sanfilippo syndrome just los...
07/17/2025

FDA said no — not to the drug, but to the paperwork.

Ultragenyx’s promising gene therapy for Sanfilippo syndrome just lost its chance for Priority Review. Why? ❌

Because the CMC documentation wasn’t strong enough.

It’s a reminder: in pharma, you can’t win on science alone.
You need a smart, strong regulatory plan — and clean, complete submissions.

💡 At ALPI Solutions, we help build exactly that.
Ready for your next milestone?

07/10/2025

💬 How are pharma teams building their Field Force today?

👉 Some companies keep it in-house
👉 Others are switching to outsourced teams
👉 Many choose a hybrid model

💡 Each option has its own pros and cons: speed, control, flexibility.

💬 What works best in your experience?
How do you manage KPIs? How do you ensure quality?
Let’s talk — your thoughts are welcome!

💊 Pharma’s Sales Model is Changing!The Contract Sales Outsourcing (CSO) market is growing fast — it could reach $24.8 bi...
07/03/2025

💊 Pharma’s Sales Model is Changing!

The Contract Sales Outsourcing (CSO) market is growing fast — it could reach $24.8 billion by 2030.

Why is this important?
👉 Pharma companies are outsourcing more Field Force and commercial teams.
👉 This means more flexible, outsourced sales models will drive future product launches.
👉 It’s a big shift that’s changing how pharma companies plan, hire, and succeed.

At ALPI Solutions, we’re here to help teams navigate this transformation.

📖 Source: GlobeNewswire Report (https://www.globenewswire.com/news-release/2025/06/05/3094568/28124/en/Pharmaceutical-Contract-Sales-Outsourcing-Industry-Business-Report-2025-Market-to-Reach-24-8-Billion-by-2030-Growing-Complexity-in-Pharmaceutical-Commercialization-Models-Propels-D.html)

Do you think outsourcing is the future of pharma sales?
💬 Share your thoughts!

💊 3 Big Pharma Updates This Week✅ FDA’s new fast-track program: critical drugs may now get approved in just 1–2 months.✅...
06/26/2025

💊 3 Big Pharma Updates This Week

✅ FDA’s new fast-track program: critical drugs may now get approved in just 1–2 months.
✅ Gilead’s new HIV prevention injection: just 2 doses per year for nearly full protection.
✅ U.S. pharma companies sign $18B+ in deals with Chinese biotech firms.

At ALPI Solutions, we follow these trends to help patients get faster access to innovation.

👉 Which news surprised you the most? Share your thoughts!

What’s happening this week in pharma? Here are 3 big updates:FDA delayed a drug approval for a rare condition due to int...
06/19/2025

What’s happening this week in pharma? Here are 3 big updates:

FDA delayed a drug approval for a rare condition due to internal staff cuts.
Sun Pharma’s U.S. plant got 8 GMP warnings from FDA.
U.S. companies licensed $18B+ in Chinese biotech drugs in just 6 months!

At ALPI Solutions, we follow these changes closely — because they impact real patients and real strategies.

Which of these trends do you think will affect the industry most?
Tell us in the comments!

💊 We’re tuning in to ASHP Pharmacy Futures 2025!From new clinical strategies to the role of pharmacists in regulatory de...
06/12/2025

💊 We’re tuning in to ASHP Pharmacy Futures 2025!

From new clinical strategies to the role of pharmacists in regulatory decisions — this week’s conference is all about shaping the future of our profession.

📍 One big takeaway?
It’s not just about medications — it’s about decisions, data, and patients.

We at ALPI Solutions love seeing how pharmacy continues to evolve and expand — and we’re proud to be part of that change.

Swipe to see how the future of pharmacy looks from the front row 👉

For people living with rare diseases, time matters.At a recent FDA meeting, U.S. Health Secretary Robert F. Kennedy Jr. ...
06/05/2025

For people living with rare diseases, time matters.

At a recent FDA meeting, U.S. Health Secretary Robert F. Kennedy Jr. announced plans to accelerate the approval of treatments for rare diseases, aiming to eliminate regulatory barriers and bolster the United States’ role in biotechnology innovation.

“We’re going to make this country the hub of biotechnology innovation.”

At ALPI Solutions, we welcome this focus on rare conditions — because every faster approval means patients get access sooner.

📍The future of biotech must be fast, safe, and focused on people.

Address

New York, NY

Telephone

+13473693896

Website

Alerts

Be the first to know and let us send you an email when ALPI Solutions posts news and promotions. Your email address will not be used for any other purpose, and you can unsubscribe at any time.

Shortcuts

Featured

Share

Category